Tissue thickness compensator comprising a plurality of capsules

ABSTRACT

A tissue thickness compensator can comprise a plurality of layers. Various embodiments are disclosed herein for manufacturing a tissue thickness compensator. In certain embodiments, a tissue thickness compensator can comprise at least one medicament tube, capsule, and/or packet contained therein

CROSS-REFERENCE TO RELATED APPLICATION

This non-provisional patent application is a continuation-in-partapplication under 35 U.S.C.§120 of U.S. patent application Ser. No.12/894,388, entitled “Fastener System Comprising A Retention Matrix AndA Cover”, filed on Sep. 30, 2010, the entire disclosure of which ishereby incorporated by reference herein.

BACKGROUND

The present invention relates to surgical instruments and, in variousembodiments, to surgical cutting and stapling instruments and staplecartridges therefor that are designed to cut and staple tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of this invention, and the manner ofattaining them, will become more apparent and the invention itself willbe better understood by reference to the following description ofembodiments of the invention taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a cross-sectional view of a surgical instrument embodiment;

FIG. 1A is a perspective view of one embodiment of an implantable staplecartridge;

FIGS. 1B-1E illustrate portions of an end effector clamping and staplingtissue with an implantable staple cartridge;

FIG. 2 is a partial cross-sectional side view of another end effectorcoupled to a portion of a surgical instrument with the end effectorsupporting a surgical staple cartridge and with the anvil thereof in anopen position;

FIG. 3 is another partial cross-sectional side view of the end effectorof FIG. 2 in a closed position;

FIG. 4 is another partial cross-sectional side view of the end effectorof FIGS. 2 and 3 as the knife bar is starting to advance through the endeffector;

FIG. 5 is another partial cross-sectional side view of the end effectorof FIGS. 2-4 with the knife bar partially advanced therethrough;

FIGS. 6A-6D diagram the deformation of a surgical staple positionedwithin a collapsible staple cartridge body in accordance with at leastone embodiment;

FIG. 7A is a diagram illustrating a staple positioned in a crushablestaple cartridge body;

FIG. 7B is a diagram illustrating the crushable staple cartridge body ofFIG. 7A being crushed by an anvil;

FIG. 7C is a diagram illustrating the crushable staple cartridge body ofFIG. 7A being further crushed by the anvil;

FIG. 7D is a diagram illustrating the staple of FIG. 7A in a fullyformed configuration and the crushable staple cartridge of FIG. 7A in afully crushed condition;

FIG. 8 is a top view of a staple cartridge in accordance with at leastone embodiment comprising staples embedded in a collapsible staplecartridge body;

FIG. 9 is an elevational view of the staple cartridge of FIG. 8;

FIG. 10 is an exploded perspective view of an alternative embodiment ofa compressible staple cartridge comprising staples therein and a systemfor driving the staples against an anvil;

FIG. 10A is a partial cut-away view of an alternative embodiment of thestaple cartridge of FIG. 10;

FIG. 11 is a cross-sectional view of the staple cartridge of FIG. 10;

FIG. 12 is an elevational view of a sled configured to traverse thestaple cartridge of FIG. 10 and move the staples to toward the anvil;

FIG. 13 is a diagram of a staple driver which can be lifted toward theanvil by the sled of FIG. 12;

FIG. 14 is a perspective view of a staple cartridge comprising a rigidsupport portion and a compressible tissue thickness compensator for usewith a surgical stapling instrument in accordance with at least oneembodiment of the invention;

FIG. 15 is a partially exploded view of the staple cartridge of FIG. 14;

FIG. 16 is a fully exploded view of the staple cartridge of FIG. 14;

FIG. 17 is another exploded view of the staple cartridge of FIG. 14without a warp covering the tissue thickness compensator;

FIG. 18 is a perspective view of a cartridge body, or support portion,of the staple cartridge of FIG. 14;

FIG. 19 is a top perspective view of a sled movable within the staplecartridge of FIG. 14 to deploy staples from the staple cartridge;

FIG. 20 is a bottom perspective view of the sled of FIG. 19;

FIG. 21 is an elevational view of the sled of FIG. 19;

FIG. 22 is a top perspective view of a driver configured to support oneor more staples and to be lifted upwardly by the sled of FIG. 19 toeject the staples from the staple cartridge;

FIG. 23 is a bottom perspective view of the driver of FIG. 22;

FIG. 24 is a wrap configured to at least partially surround acompressible tissue thickness compensator of a staple cartridge;

FIG. 25 is a partial cut away view of a staple cartridge comprising arigid support portion and a compressible tissue thickness compensatorillustrated with staples being moved from an unfired position to a firedposition during a first sequence;

FIG. 26 is an elevational view of the staple cartridge of FIG. 25;

FIG. 27 is a detail elevational view of the staple cartridge of FIG. 25;

FIG. 28 is a cross-sectional end view of the staple cartridge of FIG.25;

FIG. 29 is a bottom view of the staple cartridge of FIG. 25;

FIG. 30 is a detail bottom view of the staple cartridge of FIG. 25;

FIG. 31 is a longitudinal cross-sectional view of an anvil in a closedposition and a staple cartridge comprising a rigid support portion and acompressible tissue thickness compensator illustrated with staples beingmoved from an unfired position to a fired position during a firstsequence;

FIG. 32 is another cross-sectional view of the anvil and the staplecartridge of FIG. 31 illustrating the anvil in an open position afterthe firing sequence has been completed;

FIG. 33 is a partial detail view of the staple cartridge of FIG. 31illustrating the staples in an unfired position;

FIG. 34 is a cross-sectional elevational view of a staple cartridgecomprising a rigid support portion and a compressible tissue thicknesscompensator illustrating the staples in an unfired position;

FIG. 35 is a detail view of the staple cartridge of FIG. 34;

FIG. 36 is an elevational view of an anvil in an open position and astaple cartridge comprising a rigid support portion and a compressibletissue thickness compensator illustrating the staples in an unfiredposition;

FIG. 37 is an elevational view of an anvil in a closed position and astaple cartridge comprising a rigid support portion and a compressibletissue thickness compensator illustrating the staples in an unfiredposition and tissue captured between the anvil and the tissue thicknesscompensator;

FIG. 38 is a detail view of the anvil and staple cartridge of FIG. 37;

FIG. 39 is an elevational view of an anvil in a closed position and astaple cartridge comprising a rigid support portion and a compressibletissue thickness compensator illustrating the staples in an unfiredposition illustrating thicker tissue positioned between the anvil andthe staple cartridge;

FIG. 40 is a detail view of the anvil and staple cartridge of FIG. 39;

FIG. 41 is an elevational view of the anvil and staple cartridge of FIG.39 illustrating tissue having different thicknesses positioned betweenthe anvil and the staple cartridge;

FIG. 42 is a detail view of the anvil and staple cartridge of FIG. 39 asillustrated in FIG. 41;

FIG. 43 is a diagram illustrating a tissue thickness compensator whichis compensating for different tissue thickness captured within differentstaples;

FIG. 44 is a diagram illustrating a tissue thickness compensatorapplying a compressive pressure to one or more vessels that have beentransected by a staple line;

FIG. 45 is a diagram illustrating a circumstance wherein one or morestaples have been improperly formed;

FIG. 46 is a diagram illustrating a tissue thickness compensator whichcould compensate for improperly formed staples;

FIG. 47 is a diagram illustrating a tissue thickness compensatorpositioned in a region of tissue in which multiple staples lines haveintersected;

FIG. 48 is a diagram illustrating tissue captured within a staple;

FIG. 49 is a diagram illustrating tissue and a tissue thicknesscompensator captured within a staple;

FIG. 50 is a diagram illustrating tissue captured within a staple;

FIG. 51 is a diagram illustrating thick tissue and a tissue thicknesscompensator captured within a staple;

FIG. 52 is a diagram illustrating thin tissue and a tissue thicknesscompensator captured within a staple;

FIG. 53 is a diagram illustrating tissue having an intermediatethickness and a tissue thickness compensator captured within a staple;

FIG. 54 is a diagram illustrating tissue having another intermediatethickness and a tissue thickness compensator captured within a staple;

FIG. 55 is a diagram illustrating thick tissue and a tissue thicknesscompensator captured within a staple;

FIG. 56 is a partial cross-sectional view of an end effector of asurgical stapling instrument illustrating a firing bar and staple-firingsled in a retracted, unfired position;

FIG. 57 is another partial cross-sectional view of the end effector ofFIG. 56 illustrating the firing bar and the staple-firing sled in apartially advanced position;

FIG. 58 is a cross-sectional view of the end effector of FIG. 56illustrating the firing bar in a fully advanced, or fired, position;

FIG. 59 is a cross-sectional view of the end effector of FIG. 56illustrating the firing bar in a retracted position after being firedand the staple-firing sled left in its fully fired position;

FIG. 60 is a detail view of the firing bar in the retracted position ofFIG. 59;

FIG. 61 is a cross-sectional perspective view of an embodiment of acutting blade being advanced distally within an end effector of asurgical instrument to incise tissue;

FIG. 62 is a cross-sectional side view illustrating features on thecutting blade of FIG. 61 configured to direct a substance within atissue thickness compensator toward the tissue;

FIG. 63 is a cross-sectional perspective view of an alternativeembodiment of a cutting blade being advanced distally within an endeffector of a surgical instrument to incise tissue;

FIG. 64 is a cross-sectional perspective view of another alternativeembodiment of a cutting blade being advanced distally within an endeffector of a surgical instrument to incise tissue;

FIG. 65 is a cross-sectional side view illustrating features on thecutting blade of FIG. 64 configured to mix a substance within a firsttissue thickness compensator with a substance from a second tissuethickness compensator;

FIG. 66 is a front view illustrating features on the cutting blade ofFIG. 64 configured to mix a substance within a first tissue thicknesscompensator with a substance from a second tissue thickness compensator;

FIG. 67 is a cross-sectional top view illustrating features on thecutting blade of FIG. 64 configured to mix a substance within a firsttissue thickness compensator with a substance from a second tissuethickness compensator;

FIG. 68 is a cross-sectional perspective view of another alternativeembodiment of a cutting blade being advanced distally within an endeffector of a surgical instrument to incise tissue;

FIG. 69 is a cross-sectional side view illustrating features on thecutting blade of FIG. 68 configured to spread a substance containedwithin a tissue thickness compensator; and

FIG. 70 is a cross-sectional side view of the cutting blade of FIG. 68spreading the substance.

FIG. 71 is partial cut-away perspective view of a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 72 illustrates a medicament being loaded into a tissue thicknesscompensator;

FIG. 73 is a cross-sectional end view of a tube positioned within thetissue thickness compensator of FIG. 71 comprising a medicamentcontained therein;

FIG. 74 illustrates the tissue thickness compensator of FIG. 71 beingpositioned and compressed against a patient's tissue;

FIG. 75 is a cross-sectional end view of an end effector of a surgicalstapling instrument illustrating staples being fired through the tissuethickness compensator of FIG. 71;

FIG. 76 is a graph depicting the dissolution of a capsule containedwithin a tissue thickness compensator, wherein the capsule comprises aplurality of medicament layers;

FIG. 77 illustrates a first, or outer, layer of the capsule of FIG. 76being dissolved;

FIG. 78 illustrates a second layer of the capsule of FIG. 76 beingdissolved;

FIG. 79 illustrates a third layer of the capsule of FIG. 76 beingdissolved;

FIG. 80 illustrates a fourth, or inner, layer of the capsule of FIG. 76being dissolved;

FIG. 81 is a partial cut-away view of a staple cartridge in accordancewith at least one embodiment comprising a tissue thickness compensatorincluding a plurality of vertical capsules;

FIG. 82 is a perspective view of a vertical capsule of FIG. 81;

FIG. 83 is a partial cut-away view of the staple cartridge of FIG. 81illustrating staples contained therein in an unfired position;

FIG. 84 is a cross-sectional side view of the staple cartridge of FIG.81 illustrating the staples of FIG. 83 being moved from an unfiredposition to a fired position;

FIG. 85 is a partial cut-away view of a tissue thickness compensatorcomprising vertical capsules positioned therein in accordance with atleast one embodiment;

FIG. 86 is a partial cut-away view of a tissue thickness compensatorcomprising a plurality of capsules having openings defined therein;

FIG. 87 is a cross-sectional end view of an end effector of a surgicalstapling instrument comprising a plurality of staples in an unfiredposition and a plurality of piercing members configured to rupturecapsules or tubes contained within a tissue thickness compensator inaccordance with at least one embodiment;

FIG. 88 is an elevational view of a staple of FIG. 87 in an unfiredconfiguration;

FIG. 89 is an elevational view of the staple of FIG. 88 in a firedconfiguration;

FIG. 90 is an elevational view of a piercing member of FIG. 87;

FIG. 91 is a cross-sectional end view of the end effector of FIG. 87illustrating the staples and the piercing members in a fired position;

FIG. 92 is a cross-sectional side view of the end effector of FIG. 87illustrating the staples and the piercing members being moved from anunfired position to a fired position;

FIG. 93 is a top cut-away view of a staple cartridge in accordance withat least one embodiment including a tissue thickness compensatorcomprising a plurality of capsules positioned therein;

FIG. 94 is a detail view of the staple cartridge of FIG. 93;

FIG. 95 is a cross-sectional end view of the staple cartridge of FIG. 93positioned within an end effector illustrating staples contained withinthe staple cartridge in a fired position;

FIG. 96 is a cross-sectional end view of the staple cartridge of FIG. 93in the end effector of FIG. 95 illustrating a cutting member beingadvanced through the capsules in the tissue thickness compensator;

FIG. 97 is a perspective view of a tissue thickness compensatorcomprising a longitudinal member in accordance with at least oneembodiment;

FIG. 98 is a cross-sectional view of a mold configured to produce thetissue thickness compensator of FIG. 97;

FIG. 99 is a cross-sectional end view of the mold of FIG. 98illustrating the longitudinal member of FIG. 97 positioned therein;

FIG. 100 is a cross-sectional end view of the mold of FIG. 98illustrating tissue thickness compensator material being poured into themold of FIG. 98;

FIG. 101 is a cut-away perspective view of a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 102 is a perspective view of a support member configured to beembedded in a tissue thickness compensator in accordance with at leastone embodiment;

FIG. 103 is a cut-away perspective view of a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 104 is a cross-sectional end view illustrating a mold formanufacturing the tissue thickness compensator of FIG. 103;

FIG. 105 is a cross-sectional view of the tissue thickness compensatorof FIG. 103;

FIG. 106 is a cross-sectional side view of the mold of FIG. 104;

FIG. 107 is a cross-sectional end view of a tissue thickness compensatorin accordance with at least one embodiment;

FIG. 108 is a cross-sectional end view of another tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 109 is a detail view of a scaffold material for a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 110 is a detail view of a tissue thickness compensator in anunexpanded state in accordance with at least one embodiment;

FIG. 111 is a detail view of the tissue thickness compensator of FIG.110 in an expanded state;

FIG. 112 is a cut-away perspective view of a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 113 is a partial cut-away perspective view of a tissue thicknesscompensator being manufactured in a mold in accordance with at least oneembodiment;

FIG. 114 is a cross-sectional perspective view of a tissue thicknesscompensator in accordance with at least one alternative embodiment;

FIG. 115 is a cross-sectional end view of a tissue thickness compensatorin accordance with at least one alternative embodiment;

FIG. 116 is a partial perspective view of a tissue thickness compensatorin accordance with at least one alternative embodiment;

FIG. 117 is an elevational view of an end effector of a surgicalstapling instrument comprising a tissue thickness compensator inaccordance with at least one embodiment;

FIG. 118 is an exploded view of the tissue thickness compensator of FIG.117 wherein the tissue thickness compensator comprises a plurality oflayers;

FIG. 119 is a cross-sectional view of a layer of a tissue thicknesscompensator;

FIG. 120 is a cross-sectional view of another layer of a tissuethickness compensator;

FIG. 121 is a partial cross-sectional elevational view of the tissuethickness compensator of FIG. 117 positioned between an anvil and astaple cartridge of the surgical stapling instrument;

FIG. 122 is another partial cross-sectional elevational view of thetissue thickness compensator of FIG. 117 captured within a stapleejected from the staple cartridge and deformed by the anvil of thesurgical stapling instrument;

FIG. 123 is another partial cross-sectional elevational view of thetissue thickness compensator of FIG. 117 attached to tissue by thestaple of FIG. 122;

FIG. 124 is a perspective view of a layer of a tissue thicknesscompensator in accordance with at least one alternative embodiment;

FIG. 125 is a perspective view of an end effector of a surgical staplinginstrument comprising a tissue thickness compensator including the layerof FIG. 124;

FIG. 126 is a partial perspective view of a tissue thickness compensatorin accordance with at least one alternative embodiment;

FIG. 127 is a perspective view of an end effector of a surgical staplinginstrument comprising the tissue thickness compensator of FIG. 126;

FIG. 128 is a perspective view of a plurality of coated fibers;

FIG. 129 is a perspective view illustrating an extrusion process forproducing a coated fiber and/or a coated strand which can be dissectedinto coated fibers;

FIG. 130 is a cross-sectional perspective view of a coated fiber;

FIG. 131 is a perspective view illustrating a coating process utilizinga carrier fluid configured deposit a material on and/or within a fiber;

FIG. 132 is a perspective view of a staple cartridge including a tissuethickness compensator comprising the fibers of FIG. 128;

FIG. 133 is a partial cut-away perspective view of a tissue thicknesscompensator in accordance with at least one embodiment;

FIG. 134 is a cross-sectional view of a medicament encased by ahydrophilic material in accordance with at least one embodiment;

FIG. 135 is a perspective view of the tissue thickness compensator ofFIG. 133 positioned within an end effector of a surgical instrument;

FIG. 136 is a partial cut-away perspective view of the medicament ofFIG. 134 being exposed to a liquid such that the medicament can weep outof the tissue thickness compensator of FIG. 133;

FIG. 137 is a partial perspective view of a tissue thickness compensatorin accordance with at least one embodiment;

FIG. 138 is a partial perspective view of the tissue thicknesscompensator of FIG. 137 after it has been exposed to a liquid;

FIG. 139 is a perspective view of an end effector including the tissuethickness compensator of FIG. 137 attached to an anvil;

FIG. 140 is a partial cut-away perspective view of a tissue thicknesscompensator comprising the medicament of FIG. 134 and the fibers of FIG.128;

FIG. 141 is a partial perspective view of a staple cartridge comprisinga tissue thickness compensator including a plurality of capsules;

FIG. 142 is a side view of the staple cartridge of FIG. 141;

FIG. 143 illustrates the capsules of FIG. 141 being placed in a mold;

FIG. 144 illustrates the capsules of FIG. 141 settling to the bottom ofthe mold of FIG. 143;

FIG. 145 illustrates a compensator body material being poured over thecapsules of FIG. 141;

FIG. 146 illustrates an embodiment in which the capsules of FIG. 141 aredenser than the compensator body material and remain on the bottom ofthe mold of FIG. 143;

FIG. 147 illustrates an embodiment in which the capsules of FIG. 141 areless dense than the compensator body material and can float to the topof the mold of FIG. 143;

FIG. 148 illustrates an alternative embodiment of a mold including aplurality of recesses or dimples configured to receive the capsules ofFIG. 141;

FIG. 149 is a cross-sectional end view of an end effector of a surgicalstapling instrument comprising a tissue thickness compensator positionedover a staple cartridge in accordance with at least one embodiment;

FIG. 150 is a cross-sectional end view of the end effector of FIG. 149illustrating staples fired from the staple cartridge and extendingthrough the tissue thickness compensator of FIG. 149;

FIG. 151 illustrates a mold and a plurality of medicament capsulespositioned within the mold;

FIG. 152 is a cross-sectional end view of the mold illustrating acompensator body material being poured into the mold to form a tissuethickness compensator;

FIG. 153 is a perspective view of the tissue thickness compensator ofFIG. 152 attached to an anvil of a surgical stapling instrument;

FIG. 154 is a cross-sectional view of a mold configured to form thetissue thickness compensator of FIG. 157 illustrating a first layerbeing poured into the mold;

FIG. 155 is a cross-sectional view of the mold of FIG. 154 illustratinga capsule positioned on the first layer;

FIG. 156 is a cross-sectional view of the mold of FIG. 154 illustratinga second layer being poured onto the capsule;

FIG. 157 is a perspective view of a tissue thickness compensator inaccordance with at least one embodiment;

FIG. 158 is a perspective view of the tissue thickness compensator ofFIG. 157 positioned within an end effector of a surgical staplinginstrument;

FIG. 159 is a perspective view of a compensator body of the tissuethickness compensator of FIG. 162;

FIG. 160 is a perspective view of a longitudinal aperture defined in thecompensator body of FIG. 159;

FIG. 161 is a diagram illustrating a capsule being positioned within thelongitudinal aperture of FIG. 160;

FIG. 162 is a perspective view of an end effector of a surgical staplinginstrument including a tissue thickness compensator in accordance withat least one embodiment;

FIG. 163 is a perspective view of a compensator body of the tissuethickness compensator of FIG. 166;

FIG. 164 is a perspective view of a plurality of transverse aperturesdefined in the compensator body of FIG. 163;

FIG. 165 is a diagram illustrating capsules being positioned within thetransverse apertures of FIG. 164;

FIG. 166 is a perspective view of an end effector of a surgical staplinginstrument including a tissue thickness compensator in accordance withat least one embodiment;

FIG. 167 is a perspective view of a vertical mold configured tomanufacture a tissue thickness compensator;

FIG. 168 is a perspective view of a capsule being positioned within themold of FIG. 167;

FIG. 169 is a perspective view of the capsule of FIG. 168 positionedwithin the mold of FIG. 167;

FIG. 170 is a perspective view of a cover placed against the mold ofFIG. 167 and a compensator body material being positioned within themold;

FIG. 171 is a perspective view of the mold of FIG. 167 illustrated withthe cover of FIG. 170 removed;

FIG. 172 illustrates a staple cartridge comprising a tissue thicknesscompensator and a tissue thickness compensator mat in accordance with atleast one embodiment;

FIG. 173 is a partial bottom perspective view of the tissue thicknesscompensator mat of FIG. 172;

FIG. 174 is a partial top perspective view of the tissue thicknesscompensator mat of FIG. 172;

FIG. 175 is a partial cross-sectional view of the staple cartridge ofFIG. 172 being fired by a firing member, wherein the staple cartridge isillustrated without the tissue thickness compensator positioned thereon;

FIG. 176 is a top view of the tissue thickness compensator mat of FIG.172 being incised by a cutting member engaged with the firing member ofFIG. 175, wherein the staple cartridge is illustrated without the tissuethickness compensator positioned thereon;

FIG. 177 is a top view of the tissue thickness compensator mat of FIG.172 being incised by a cutting member engaged with the firing member ofFIG. 175, wherein the staple cartridge is illustrated with the tissuethickness compensator positioned thereon;

FIG. 178 is a plan view of a circular staple cartridge in accordancewith at least one alternative embodiment comprising a circular tissuethickness compensator mat;

FIG. 179 illustrates a mold comprising a plurality of cavitiesconfigured to form tissue thickness compensators on a plurality ofstaple cartridge bodies simultaneously;

FIG. 180 illustrates staple cartridge bodies positioned within thecavities of FIG. 179 and one or more sheets being placed over thecartridge bodies;

FIG. 181 illustrates the sheets of FIG. 180 secured in place within themold of FIG. 179;

FIG. 182 illustrates an elongate tube member wound around a plurality ofpost supports within the mold of FIG. 179;

FIG. 183 illustrates the sheets of FIG. 180 secured in place over thestaple cartridge bodies of FIG. 179;

FIG. 184 illustrates the tube members of FIG. 182 in position over thesheets of FIG. 180;

FIG. 185 illustrates a compensator body material being poured into themold of FIG. 179;

FIG. 186 illustrates a cutting die positioned over the mold of FIG. 179;

FIG. 187 illustrates the cutting die moved downwardly to cut thecompensator body material of FIG. 185 and the sheets of FIG. 180;

FIG. 188 illustrates the cutting die moved upwardly away from the moldof FIG. 179;

FIG. 189 is a cross-sectional end view of a tissue thickness compensatorthat is produced by the manufacturing process outlined in FIGS. 179-188in accordance with at least one embodiment;

FIG. 190 is a top view of a staple cartridge comprising a tissuethickness compensator in accordance with at least one embodiment;

FIG. 191 is a perspective view of the staple cartridge of FIG. 190;

FIG. 192 is an illustration depicting the manufacture of the tissuethickness compensator of the staple cartridge of FIG. 190;

FIG. 193 is an illustration of rollers flattening a tube of material toform a tissue thickness compensator in accordance with at least oneembodiment;

FIG. 194 is an illustration of rollers forming a tissue thicknesscompensator in accordance with at least one alternative embodiment;

FIG. 195 is a partial perspective view of a staple cartridge includingtissue thickness compensators produced by the process illustrated inFIG. 194;

FIG. 196 is cross-sectional elevational view of staples being deployedfrom the staple cartridge of FIG. 195; and

FIG. 197 is a cross-sectional end view of staples being deployed fromthe staple cartridge of FIG. 195.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate certain embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. patentapplications identified below which are each herein incorporated byreference in their respective entirety:

-   U.S. patent application Ser. No. 12/894,311, entitled SURGICAL    INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS (Attorney Docket No.    END6734USNP/100058);-   U.S. patent application Ser. No. 12/894,340, entitled SURGICAL    STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND    SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS    (Attorney Docket No. END6735USNP/100059);-   U.S. patent application Ser. No. 12/894,327, entitled JAW CLOSURE    ARRANGEMENTS FOR SURGICAL INSTRUMENTS (Attorney Docket No.    END6736USNP/100060);-   U.S. patent application Ser. No. 12/894,351, entitled SURGICAL    CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT    FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS (Attorney Docket No.    END6839USNP/100524);-   U.S. patent application Ser. No. 12/894,338, entitled IMPLANTABLE    FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT (Attorney Docket    No. END6840USNP/100525);-   U.S. patent application Ser. No. 12/894,369, entitled IMPLANTABLE    FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER (Attorney Docket    No. END6841USNP/100526);-   U.S. patent application Ser. No. 12/894,312, entitled IMPLANTABLE    FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS (Attorney Docket No.    END6842USNP/100527);-   U.S. patent application Ser. No. 12/894,377, entitled SELECTIVELY    ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE (Attorney Docket No.    END6843USNP/100528);-   U.S. patent application Ser. No. 12/894,339, entitled SURGICAL    STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT    (Attorney Docket No. END6847USNP/100532);-   U.S. patent application Ser. No. 12/894,360, entitled SURGICAL    STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM (Attorney    Docket No. END6848USNP/100533);-   U.S. patent application Ser. No. 12/894,322, entitled SURGICAL    STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE    ARRANGEMENTS (Attorney Docket No. END6849USNP/100534);-   U.S. patent application Ser. No. 12/894,350, entitled SURGICAL    STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL    STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS    WHEN A CARTRIDGE IS NOT PRESENT (Attorney Docket No.    END6855USNP/100540);-   U.S. patent application Ser. No. 12/894,383, entitled IMPLANTABLE    FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS (Attorney Docket    No. END6856USNP/100541);-   U.S. patent application Ser. No. 12/894,389, entitled COMPRESSIBLE    FASTENER CARTRIDGE (Attorney Docket No. END6857USNP/100542);-   U.S. patent application Ser. No. 12/894,345, entitled FASTENERS    SUPPORTED BY A FASTENER CARTRIDGE SUPPORT (Attorney Docket No.    END6858USNP/100543);-   U.S. patent application Ser. No. 12/894,306, entitled COLLAPSIBLE    FASTENER CARTRIDGE (Attorney Docket No. END6859USNP/100544);-   U.S. patent application Ser. No. 12/894,318, entitled FASTENER    SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS    (Attorney Docket No. END6860USNP/100546);-   U.S. patent application Ser. No. 12/894,330, entitled FASTENER    SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX    (Attorney Docket No. END6861USNP/100547);-   U.S. patent application Ser. No. 12/894,361, entitled FASTENER    SYSTEM COMPRISING A RETENTION MATRIX (Attorney Docket No.    END6862USNP/100548);-   U.S. patent application Ser. No. 12/894,367, entitled FASTENING    INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION    MATRIX (Attorney Docket No. END6863USNP/100549);-   U.S. patent application Ser. No. 12/894,388, entitled FASTENER    SYSTEM COMPRISING A RETENTION MATRIX AND A COVER (Attorney Docket    No. END6864USNP/100550);-   U.S. patent application Ser. No. 12/894,376, entitled FASTENER    SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES (Attorney    Docket No. END6865USNP/100551);-   U.S. patent application Serial No. 13/097,865, entitled SURGICAL    STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS (Attorney    Docket No. END6735USCIP1/100059CIP1);-   U.S. patent application Serial No. 13/097,936, entitled TISSUE    THICKNESS COMPENSATOR FOR A SURGICAL STAPLER (Attorney Docket No.    END6736USCIP1/100060CIP1);-   U.S. patent application Serial No. 13/097,954, entitled STAPLE    CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION    (Attorney Docket No. END6840USCIP1/100525CIP1);-   U.S. patent application Ser. No. 13/097,856, entitled STAPLE    CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE    PORTION THEREOF (Attorney Docket No. END6841USCIP1/100526CIP1);-   U.S. patent application Serial No. 13/097,928, entitled TISSUE    THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS (Attorney    Docket No. END6842USCIP1/100527CIP1);-   U.S. patent application Serial No. 13/097,891, entitled TISSUE    THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN    ADJUSTABLE ANVIL (Attorney Docket No. END6843USCIP1/100528CIP1);-   U.S. patent application Ser. No. 13/097,948, entitled STAPLE    CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION (Attorney Docket    No. END6847USCIP1/100532CIP1);-   U.S. patent application Ser. No. 13/097,907, entitled COMPRESSIBLE    STAPLE CARTRIDGE ASSEMBLY (Attorney Docket No.    END6848USCIP1/100533CIP1);-   U.S. patent application Ser. No. 13/097,861, entitled TISSUE    THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT    PROPERTIES (Attorney Docket No. END6849USCIP1/100534CIP1);-   U.S. patent application Ser. No. 13/097,869, entitled STAPLE    CARTRIDGE LOADING ASSEMBLY (Attorney Docket No.    END6855USCIP1/100540CIP1);-   U.S. patent application Ser. No. 13/097,917, entitled COMPRESSIBLE    STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS (Attorney Docket No.    END6856USCIP1/100541CIP1);-   U.S. patent application Ser. No. 13/097,873, entitled STAPLE    CARTRIDGE COMPRISING A RELEASABLE PORTION (Attorney Docket No.    END6857USCIP1/100542CIP1);-   U.S. patent application Ser. No. 13/097,938, entitled STAPLE    CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS    (Attorney Docket No. END6858USCIP1/100543CIP1);-   U.S. patent application Ser. No. 13/097,924, entitled STAPLE    CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR (Attorney Docket    No. END6859USCIP1/100544CIP1);-   U.S. patent application Ser. No. 13/242,029, entitled SURGICAL    STAPLER WITH FLOATING ANVIL (Attorney Docket No.    END6841USCIP2/100526CIP2);-   U.S. patent application Ser. No. 13/242,066, entitled CURVED END    EFFECTOR FOR A STAPLING INSTRUMENT (Attorney Docket No.    END6841USCIP3/100526CIP3);-   U.S. patent application Ser. No. 13/242,086, entitled STAPLE    CARTRIDGE INCLUDING COLLAPSIBLE DECK (Attorney Docket No.    END7020USNP/110374);-   U.S. patent application Ser. No. 13/241,912, entitled STAPLE    CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT (Attorney Docket    No. END7019USNP/110375);-   U.S. patent application Ser. No. 13/241,922, entitled SURGICAL    STAPLER WITH STATIONARY STAPLE DRIVERS (Attorney Docket No.    END7013USNP/110377);-   U.S. patent application Ser. No. 13/241,637, entitled SURGICAL    INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION    MOTIONS (Attorney Docket No. END6888USNP3/110378); and-   U.S. patent application Ser. No. 13/241,629, entitled SURGICAL    INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR (Attorney    Docket No. END6888USNP2/110379).

The Applicant of the present application also owns the U.S. patentapplications identified below which were filed on even date herewith andwhich are each herein incorporated by reference in their respectiveentirety:

-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING A PLURALITY OF LAYERS, (Attorney Docket No.    END6864USCIP2/100550CIP2);-   U.S. application Ser. No. ______, entitled EXPANDABLE TISSUE    THICKNESS COMPENSATOR, (Attorney Docket No.    END6843USCIP2/100528CIP2).-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING A RESERVOIR, (Attorney Docket No.    END6843USCIP3/100528CIP3);-   U.S. application Ser. No. ______, entitled RETAINER ASSEMBLY    INCLUDING A TISSUE THICKNESS COMPENSATOR, (Attorney Docket No.    END6843USCIP4/100528CIP4);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT, (Attorney Docket No.    END6843USCIP5/100528CIP5);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION, (Attorney    Docket No. END6843USCIP6/100528CIP6);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD, (Attorney    Docket No. END6843USCIP7/100528CIP7);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD,    (Attorney Docket No. END6843USCIP8/100528CIP8);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING RESILIENT MEMBERS, (Attorney Docket No.    END6843USCIP9/100528CIP9);-   U.S. application Ser. No. ______, entitled METHODS FOR FORMING    TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS,    (Attorney Docket No. END6843USCIP10/100528CP10);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATORS, (Attorney Docket No. END6843USCIP11/100528CP11);-   U.S. application Ser. No. ______, entitled LAYERED TISSUE THICKNESS    COMPENSATOR, (Attorney Docket No. END6843USCIP12/100528CP12);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS, (Attorney Docket No.    END6843USCIP13/100528CP13);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT,    (Attorney Docket No. END7100USNP/110601);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS, (Attorney Docket    No. END7101USNP/110602);-   U.S. application Ser. No. ______, entitled MOVABLE MEMBER FOR USE    WITH A TISSUE THICKNESS COMPENSATOR, (Attorney Docket No.    END7107USNP/110603);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS, (Attorney Docket    No. END7102USNP/110604);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR AND METHOD FOR MAKING THE SAME, (Attorney Docket No.    END7103USNP/110605);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING CHANNELS, (Attorney Docket No.    END7104USNP/110606);-   U.S. application Ser. No. ______, entitled TISSUE THICKNESS    COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES, (Attorney Docket    No. END7105USNP/110607); and-   U.S. application Ser. No. ______, entitled DEVICES AND METHODS FOR    ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL    STAPLING INSTRUMENTS, (Attorney Docket No. END7106USNP/110608).

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment”, or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

Turning to the Drawings wherein like numerals denote like componentsthroughout the several views, FIG. 1 depicts a surgical instrument 10that is capable of practicing several unique benefits. The surgicalstapling instrument 10 is designed to manipulate and/or actuate variousforms and sizes of end effectors 12 that are operably attached thereto.In the embodiment depicted in FIGS. 1-1E, for example, the end effector12 includes an elongated channel 14 that forms a lower jaw 13 of the endeffector 12. The elongated channel 14 is configured to support an“implantable” staple cartridge 30 and also movably support an anvil 20that functions as an upper jaw 15 of the end effector 12.

In various embodiments, the elongated channel 14 may be fabricated from,for example, 300 & 400 Series, 17-4 & 17-7 stainless steel, titanium,etc. and be formed with spaced side walls 16. The anvil 20 may befabricated from, for example, 300 & 400 Series, 17-4 & 17-7 stainlesssteel, titanium, etc. and have a staple forming undersurface, generallylabeled as 22 that has a plurality of staple forming pockets 23 formedtherein. See FIGS. 1B-1E. In addition, the anvil 20 has a bifurcatedramp assembly 24 that protrudes proximally therefrom. An anvil pin 26protrudes from each lateral side of the ramp assembly 24 to be receivedwithin a corresponding slot or opening 18 in the side walls 16 of theelongated channel 14 to facilitate its movable or pivotable attachmentthereto.

Various forms of implantable staple cartridges may be employed with thevarious embodiments of the surgical instruments disclosed herein.Specific staple cartridge configurations and constructions will bediscussed in further detail below. However, in the embodiment depictedin FIG. 1A, an implantable staple cartridge 30 is shown. In at least oneembodiment, the staple cartridge 30 has a body portion 31 that consistsof a compressible hemostat material such as, for example, oxidizedregenerated cellulose (“ORC”) or a bio-absorbable foam in which lines ofunformed metal staples 32 are supported. In at least some embodiments,in order to prevent the staple from being affected and the hemostatmaterial from being activated during the introduction and positioningprocess, the entire cartridge may be coated or wrapped in abiodegradable film 38 such as a polydioxanon film sold under thetrademark PDS® or with a Polyglycerol sebacate (PGS) film or otherbiodegradable films formed from PGA (Polyglycolic acid, marketed underthe trade mark Vicryl), PCL (Polycaprolactone), PLA or PLLA (Polylacticacid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold underthe trademark Monocryl) or a composite of PGA, PCL, PLA, PDS that wouldbe impermeable until ruptured. The body 31 of staple cartridge 30 issized to be removably supported within the elongated channel 14 as shownsuch that each staple 32 therein is aligned with corresponding stapleforming pockets 23 in the anvil when the anvil 20 is driven into formingcontact with the staple cartridge 30.

In use, once the end effector 12 has been positioned adjacent the targettissue, the end effector 12 is manipulated to capture or clamp thetarget tissue between an upper face 36 of the staple cartridge 30 andthe staple forming surface 22 of the anvil 20. The staples 32 are formedby moving the anvil 20 in a path that is substantially parallel to theelongated channel 14 to bring the staple forming surface 22 and, moreparticularly, the staple forming pockets 23 therein into substantiallysimultaneous contact with the upper face 36 of the staple cartridge 30.As the anvil 20 continues to move into the staple cartridge 30, the legs34 of the staples 32 contact a corresponding staple forming pocket 23 inanvil 20 which serves to bend the staple legs 34 over to form thestaples 32 into a “B shape”. Further movement of the anvil 20 toward theelongated channel 14 will further compress and form the staples 32 to adesired final formed height “FF”.

The above-described staple forming process is generally depicted inFIGS. 1B-1E. For example, FIG. 1B illustrates the end effector 12 withtarget tissue “T” between the anvil 20 and the upper face 36 of theimplantable staple cartridge 30. FIG. 1C illustrates the initialclamping position of the anvil 20 wherein the anvil has 20 been closedonto the target tissue “T” to clamp the target tissue “T” between theanvil 20 and the upper face 36 of the staple cartridge 30. FIG. 1Dillustrates the initial staple formation wherein the anvil 20 hasstarted to compress the staple cartridge 30 such that the legs 34 of thestaples 32 are starting to be formed by the staple forming pockets 23 inthe anvil 20. FIG. 1E illustrates the staple 32 in its final formedcondition through the target tissue “T” with the anvil 20 removed forclarity purposes. Once the staples 32 have been formed and fastened tothe target tissue “T”, the surgeon will move the anvil 20 to the openposition to enable the cartridge body 31 and the staples 32 to remainaffixed to the target tissue while the end effector 12 is beingwithdrawn from the patient. The end effector 12 forms all of the staplessimultaneously as the two jaws 13, 15 are clamped together. Theremaining “crushed” body materials 31 act as both a hemostat (the ORC)and a staple line reinforcement (PGA, PDS or any of the other filmcompositions mentioned above 38). Also, since the staples 32 never haveto leave the cartridge body 31 during forming, the likelihood of thestaples 32 being malformed during forming is minimized. As used hereinthe term “implantable” means that, in addition to the staples, thecartridge body materials that support the staples will also remain inthe patient and may eventually be absorbed by the patient's body. Suchimplantable staple cartridges are distinguishable from prior cartridgearrangements that remain positioned within the end effector in theirentirety after they have been fired.

In various implementations, the end effector 12 is configured to becoupled to an elongated shaft assembly 40 that protrudes from a handleassembly 100. The end effector 12 (when closed) and the elongated shaftassembly 40 may have similar cross-sectional shapes and be sized tooperably pass through a trocar tube or working channel in another formof access instrument. As used herein, the term “operably pass” meansthat the end effector and at least a portion of the elongated shaftassembly may be inserted through or passed through the channel or tubeopening and can be manipulated therein as needed to complete thesurgical stapling procedure. In some embodiments, when in a closedposition, the jaws 13 and 15 of the end effector 12 may provide the endeffector with a roughly circular cross-sectional shape that facilitatesits passage through a circular passage/opening. However, the endeffectors of various embodiments of the present invention, as well asthe elongated shaft assembly embodiments, could conceivably be providedwith other cross-sectional shapes that could otherwise pass throughaccess passages and openings that have non-circular cross-sectionalshapes. Thus, an overall size of a cross-section of a closed endeffector will be related to the size of the passage or opening throughwhich it is intended to pass. Thus, one end effector for example, may bereferred to as a “5 mm” end effector which means it can operably passthrough an opening that is at least approximately 5 mm in diameter.

In various embodiments, the elongated shaft assembly 40 may have anouter diameter that is substantially the same as the outer diameter ofthe end effector 12 when in a closed position. For example, a 5 mm endeffector may be coupled to an elongated shaft assembly 40 that has 5 mmcross-sectional diameter. However, as the present Detailed Descriptionproceeds, it will become apparent that various embodiments of thepresent may be effectively used in connection with different sizes ofend effectors. For example, a 10 mm end effector may be attached to anelongated shaft that has a 5 mm cross-sectional diameter. Conversely,for those applications wherein a 10 mm or larger access opening orpassage is provided, the elongated shaft assembly 40 may have a 10 mm(or larger) cross-sectional diameter, but may also be able to actuate a5 mm or 10 mm end effector. Accordingly, the outer shaft 40 may have anouter diameter that is the same as or is different from the outerdiameter of a closed end effector 12 attached thereto.

As depicted, the elongated shaft assembly 40 extends distally from thehandle assembly 100 in a generally straight line to define alongitudinal axis A-A. In various embodiments, for example, theelongated shaft assembly 40 may be approximately 9-16 inches (229-406mm) long. However, the elongated shaft assembly 40 may be provided inother lengths and, in other embodiments, may have joints therein or beotherwise configured to facilitate articulation of the end effector 12relative to other portions of the shaft or handle assembly as will bediscussed in further detail below. In various embodiments, the elongatedshaft assembly 40 includes a spine member 50 that extends from thehandle assembly 100 to the end effector 12. The proximal end of theelongated channel 14 of the end effector 12 has a pair of retentiontrunnions 17 protruding therefrom that are sized to be received withincorresponding trunnion openings or cradles 52 that are provided in adistal end of the spine member 50 to enable the end effector 12 to beremovably coupled the elongated shaft assembly 40. The spine member 50may be fabricated from, for example, 6061 or 7075 aluminum, stainlesssteel, titanium, etc.

In various embodiments, the handle assembly 100 comprises a pistolgrip-type housing that may be fabricated in two or more pieces forassembly purposes. For example, the handle assembly 100 as showncomprises a right hand case member 102 and a left hand case member (notillustrated) that are molded or otherwise fabricated from a polymer orplastic material and are designed to mate together. Such case membersmay be attached together by snap features, pegs and sockets molded orotherwise formed therein and/or by adhesive, screws, etc. The spinemember 50 has a proximal end 54 that has a flange 56 formed thereon. Theflange 56 is configured to be rotatably supported within a groove 106formed by mating ribs 108 that protrude inwardly from each of the casemembers 102, 104. Such arrangement facilitates the attachment of thespine member 50 to the handle assembly 100 while enabling the spinemember 50 to be rotated relative to the handle assembly 100 about thelongitudinal axis A-A in a 360° path.

As can be further seen in FIG. 1, the spine member 50 passes through andis supported by a mounting bushing 60 that is rotatably affixed to thehandle assembly 100. The mounting bushing 60 has a proximal flange 62and a distal flange 64 that define a rotational groove 65 that isconfigured to rotatably receive a nose portion 101 of the handleassembly 100 therebetween. Such arrangement enables the mounting bushing60 to rotate about longitudinal axis A-A relative to the handle assembly100. The spine member 50 is non-rotatably pinned to the mounting bushing60 by a spine pin 66. In addition, a rotation knob 70 is attached to themounting bushing 60. In one embodiment, for example, the rotation knob70 has a hollow mounting flange portion 72 that is sized to receive aportion of the mounting bushing 60 therein. In various embodiments, therotation knob 70 may be fabricated from, for example, glass or carbonfilled Nylon, polycarbonate, Ultem®, etc. and is affixed to the mountingbushing 60 by the spine pin 66 as well. In addition, an inwardlyprotruding retention flange 74 is formed on the mounting flange portion72 and is configured to extend into a radial groove 68 formed in themounting bushing 60. Thus, the surgeon may rotate the spine member 50(and the end effector 12 attached thereto) about longitudinal axis A-Ain a 360° path by grasping the rotation knob 70 and rotating it relativeto the handle assembly 100.

In various embodiments, the anvil 20 is retained in an open position byan anvil spring 21 and/or another biasing arrangement. The anvil 20 isselectively movable from the open position to various closed or clampingand firing positions by a firing system, generally designated as 109.The firing system 109 includes a “firing member” 110 which, in variousembodiments, comprises a hollow firing tube 110. The hollow firing tube110 is axially movable on the spine member 50 and thus forms the outerportion of the elongated shaft assembly 40. The firing tube 110 may befabricated from a polymer or other suitable material and have a proximalend that is attached to a firing yoke 114 of the firing system 109. Invarious embodiments for example, the firing yoke 114 may be over-moldedto the proximal end of the firing tube 110. However, other fastenerarrangements may be employed.

As can be seen in FIG. 1, the firing yoke 114 may be rotatably supportedwithin a support collar 120 that is configured to move axially withinthe handle assembly 100. In various embodiments, the support collar 120has a pair of laterally extending fins that are sized to be slidablyreceived within fin slots formed in the right and left hand casemembers. Thus, the support collar 120 may slide axially within thehandle housing 100 while enabling the firing yoke 114 and firing tube110 to rotate relative thereto about the longitudinal axis A-A. Invarious embodiments, a longitudinal slot is provided through the firingtube 110 to enable the spine pin 66 to extend therethrough into thespine member 50 while facilitating the axial travel of the firing tube110 on the spine member 50.

The firing system 109 further comprises a firing trigger 130 whichserves to control the axial travel of the firing tube 110 on the spinemember 50. See FIG. 1. Such axial movement in the distal direction ofthe firing tube 110 into firing interaction with the anvil 20 isreferred to herein as “firing motion”. As can be seen in FIG. 1, thefiring trigger 130 is movably or pivotally coupled to the handleassembly 100 by a pivot pin 132. A torsion spring 135 is employed tobias the firing trigger 130 away from the pistol grip portion 107 of thehandle assembly 100 to an un-actuated “open” or starting position. Ascan be seen in FIG. 1, the firing trigger 130 has an upper portion 134that is movably attached to (pinned) firing links 136 that are movablyattached to (pinned) the support collar 120. Thus, movement of thefiring trigger 130 from the starting position (FIG. 1) toward an endingposition adjacent the pistol grip portion 107 of the handle assembly 100will cause the firing yoke 114 and the firing tube 110 to move in thedistal direction “DD”. Movement of the firing trigger 130 away from thepistol grip portion 107 of the handle assembly 100 (under the bias ofthe torsion spring 135) will cause the firing yoke 114 and firing tube110 to move in the proximal direction “PD” on the spine member 50.

Various embodiments of the present invention may be employed withdifferent sizes and configurations of implantable staple cartridges. Forexample, the surgical instrument 10, when used in connection with afirst firing adapter 140, may be used with a 5 mm end effector 12 thatis approximately 20 mm long (or in other lengths) which supports animplantable staple cartridge 30. Such end effector size may beparticularly well-suited, for example, to complete relatively finedissection and vascular transactions. However, as will be discussed infurther detail below, the surgical instrument 10 may also be employed,for example, in connection with other sizes of end effectors and staplecartridges by replacing the first firing adapter 140 with a secondfiring adapter. In still other embodiments, the elongated shaft assembly40 may configured to be attached to only one form or size of endeffector.

One method of removably coupling the end effector 12 to the spine member50 will now be explained. The coupling process is commenced by insertingthe retention trunnions 17 on the elongated channel 14 into the trunnioncradles 52 in the spine member 50. Thereafter, the surgeon advances thefiring trigger 130 toward the pistol grip 107 of the housing assembly100 to distally advance the firing tube 110 and the first firing adapter140 over a proximal end portion 47 of the elongated channel 14 tothereby retain the trunnions 17 in their respective cradles 52. Suchposition of the first firing adapter 140 over the trunnions 17 isreferred to herein as the “coupled position”. Various embodiments of thepresent invention may also have an end effector locking assembly forlocking the firing trigger 130 in position after an end effector 12 hasbeen attached to the spine member 50.

More specifically, one embodiment of the end effector locking assembly160 includes a retention pin 162 that is movably supported in the upperportion 134 of the firing trigger 130. As discussed above, the firingtube 110 must initially be advanced distally to the coupled positionwherein the first firing adapter 140 retains the retention trunnions 17of the end effector 12 in the trunnion cradles 52 in the spine member50. The surgeon advances the firing adapter 140 distally to the coupledposition by pulling the firing trigger 130 from the starting positiontoward the pistol grip 107. As the firing trigger 130 is initiallyactuated, the retention pin 162 is moved distally until the firing tube110 has advanced the first firing adapter 140 to the coupled position atwhich point the retention pin 162 is biased into a locking cavity 164formed in the case member. In various embodiments, when the retentionpin 162 enters into the locking cavity 164, the pin 162 may make anaudible “click” or other sound, as well as provide a tactile indicationto the surgeon that the end effector 12 has been “locked” onto the spinemember 50. In addition, the surgeon cannot inadvertently continue toactuate the firing trigger 130 to start to form staples 32 in the endeffector 12 without intentionally biasing the retention pin 162 out ofthe locking cavity 164. Similarly, if the surgeon releases the firingtrigger 130 when in the coupled position, it is retained in thatposition by the retention pin 162 to prevent the firing trigger 130 fromreturning to the starting position and thereby releasing the endeffector 12 from the spine member 50.

Various embodiments of the present invention may further include afiring system lock button 137 that is pivotally attached to the handleassembly 100. In one form, the firing system lock button 137 has a latch138 formed on a distal end thereof that is oriented to engage the firingyoke 114 when the firing release button is in a first latching position.As can be seen in FIG. 1, a latch spring 139 serves to bias the firingsystem lock button 137 to the first latching position. In variouscircumstances, the latch 138 serves to engage the firing yoke 114 at apoint where the position of the firing yoke 114 on the spine member 50corresponds to a point wherein the first firing adapter 140 is about todistally advance up the clamping ramp 28 on the anvil 20. It will beunderstood that, as the first firing adapter 140 advances axially up theclamping ramp 28, the anvil 20 will move in a path such that its stapleforming surface portion 22 is substantially parallel to the upper face36 of the staple cartridge 30.

After the end effector 12 has been coupled to the spine member 50, thestaple forming process is commenced by first depressing the firingsystem lock button 137 to enable the firing yoke 114 to be further moveddistally on the spine member 50 and ultimately compress the anvil 20into the staple cartridge 30. After depressing the firing system lockbutton 137, the surgeon continues to actuate the firing trigger 130towards the pistol grip 107 thereby driving the first staple collar 140up the corresponding staple forming ramp 29 to force the anvil 20 intoforming contact with the staples 32 in the staple cartridge 30. Thefiring system lock button 137 prevents the inadvertent forming of thestaples 32 until the surgeon is ready to start that process. In thisembodiment, the surgeon must depress the firing system lock button 137before the firing trigger 130 may be further actuated to begin thestaple forming process.

The surgical instrument 10 may be solely used as a tissue staplingdevice if so desired. However, various embodiments of the presentinvention may also include a tissue cutting system, generally designatedas 170. In at least one form, the tissue cutting system 170 comprises aknife member 172 that may be selectively advanced from an un-actuatedposition adjacent the proximal end of the end effector 12 to an actuatedposition by actuating a knife advancement trigger 200. The knife member172 is movably supported within the spine member 50 and is attached orotherwise protrudes from a knife rod 180. The knife member 172 may befabricated from, for example, 420 or 440 stainless steel with a hardnessof greater than 38HRC (Rockwell Hardness C-scale) and have a tissuecutting edge 176 formed on the distal end 174 thereof and be configuredto slidably extend through a slot in the anvil 20 and a centrallydisposed slot 33 in the staple cartridge 30 to cut through tissue thatis clamped in the end effector 12. In various embodiments, the knife rod180 extends through the spine member 50 and has a proximal end portionwhich drivingly interfaces with a knife transmission that is operablyattached to the knife advance trigger 200. In various embodiments, theknife advance trigger 200 is attached to pivot pin 132 such that it maybe pivoted or otherwise actuated without actuating the firing trigger130. In various embodiments, a first knife gear 192 is also attached tothe pivot pin 132 such that actuation of the knife advance trigger 200also pivots the first knife gear 192. A firing return spring 202 isattached between the first knife gear 192 and the handle housing 100 tobias the knife advancement trigger 200 to a starting or un-actuatedposition.

Various embodiments of the knife transmission also include a secondknife gear 194 that is rotatably supported on a second gear spindle andin meshing engagement with the first knife gear 192. The second knifegear 194 is in meshing engagement with a third knife gear 196 that issupported on a third gear spindle. Also supported on the third gearspindle 195 is a fourth knife gear 198. The fourth knife gear 198 isadapted to drivingly engage a series of annular gear teeth or rings on aproximal end of the knife rod 180. Thus, such arrangement enables thefourth knife gear 198 to axially drive the knife rod 180 in the distaldirection “DD” or proximal direction “PD” while enabling the firing rod180 to rotate about longitudinal axis A-A with respect to the fourthknife gear 198. Accordingly, the surgeon may axially advance the firingrod 180 and ultimately the knife member 172 distally by pulling theknife advancement trigger 200 towards the pistol grip 107 of the handleassembly 100.

Various embodiments of the present invention further include a knifelockout system 210 that prevents the advancement of the knife member 172unless the firing trigger 130 has been pulled to the fully firedposition. Such feature will therefore prevent the activation of theknife advancement system 170 unless the staples have first been fired orformed into the tissue. As can be seen in FIG. 1, variousimplementations of the knife lockout system 210 comprise a knife lockoutbar 211 that is pivotally supported within the pistol grip portion 107of the handle assembly 100. The knife lockout bar 211 has an activationend 212 that is adapted to be engaged by the firing trigger 130 when thefiring trigger 130 is in the fully fired position. In addition, theknife lockout bar 211 has a retaining hook 214 on its other end that isadapted to hookingly engage a latch rod 216 on the first cut gear 192. Aknife lock spring 218 is employed to bias the knife lockout bar 211 to a“locked” position wherein the retaining hook 214 is retained inengagement with the latch rod 216 to thereby prevent actuation of theknife advancement trigger 200 unless the firing trigger 130 is in thefully fired position.

After the staples have been “fired” (formed) into the target tissue, thesurgeon may depress the firing trigger release button 167 to enable thefiring trigger 130 to return to the starting position under the bias ofthe torsion spring 135 which enables the anvil 20 to be biased to anopen position under the bias of spring 21. When in the open position,the surgeon may withdraw the end effector 12 leaving the implantablestaple cartridge 30 and staples 32 behind. In applications wherein theend effector was inserted through a passage, working channel, etc. thesurgeon will return the anvil 20 to the closed position by activatingthe firing trigger 130 to enable the end effector 12 to be withdrawn outthrough the passage or working channel. If, however, the surgeon desiresto cut the target tissue after firing the staples, the surgeon activatesthe knife advancement trigger 200 in the above-described manner to drivethe knife bar 172 through the target tissue to the end of the endeffector. Thereafter, the surgeon may release the knife advancementtrigger 200 to enable the firing return spring 202 to cause the firingtransmission to return the knife bar 172 to the starting (un-actuated)position. Once the knife bar 172 has been returned to the startingposition, the surgeon may open the end effector jaws 13, 15 to releasethe implantable cartridge 30 within the patient and then withdraw theend effector 12 from the patient. Thus, such surgical instrumentsfacilitate the use of small implantable staple cartridges that may beinserted through relatively smaller working channels and passages, whileproviding the surgeon with the option to fire the staples withoutcutting tissue or if desired to also cut tissue after the staples havebeen fired.

Various unique and novel embodiments of the present invention employ acompressible staple cartridge that supports staples in a substantiallystationary position for forming contact by the anvil. In variousembodiments, the anvil is driven into the unformed staples wherein, inat least one such embodiment, the degree of staple formation attained isdependent upon how far the anvil is driven into the staples. Such anarrangement provides the surgeon with the ability to adjust the amountof forming or firing pressure applied to the staples and thereby alterthe final formed height of the staples. In other various embodiments ofthe present invention, surgical stapling arrangements can employ stapledriving elements which can lift the staples toward the anvil. Suchembodiments are described in greater detail further below.

In various embodiments, with regard to the embodiments described indetail above, the amount of firing motion that is applied to the movableanvil is dependent upon the degree of actuation of the firing trigger.For example, if the surgeon desires to attain only partially formedstaples, then the firing trigger is only partially depressed inwardtowards the pistol grip 107. To attain more staple formation, thesurgeon simply compresses the firing trigger further which results inthe anvil being further driven into forming contact with the staples. Asused herein, the term “forming contact” means that the staple formingsurface or staple forming pockets have contacted the ends of the staplelegs and have started to form or bend the legs over into a formedposition. The degree of staple formation refers to how far the staplelegs have been folded over and ultimately relates to the forming heightof the staple as referenced above. Those of ordinary skill in the artwill further understand that, because the anvil 20 moves in asubstantially parallel relationship with respect to the staple cartridgeas the firing motions are applied thereto, the staples are formedsubstantially simultaneously with substantially the same formed heights.

FIGS. 2 and 3 illustrate an alternative end effector 12″ that is similarto the end effector 12′ described above, except with the followingdifferences that are configured to accommodate a knife bar 172′. Theknife bar 172′ is coupled to or protrudes from a knife rod 180 and isotherwise operated in the above described manner with respect to theknife bar 172. However, in this embodiment, the knife bar 172′ is longenough to traverse the entire length of the end effector 12″ andtherefore, a separate distal knife member is not employed in the endeffector 12″. The knife bar 172′ has an upper transverse member 173′ anda lower transverse member 175′ formed thereon. The upper transversemember 173′ is oriented to slidably transverse a corresponding elongatedslot 250 in anvil 20″ and the lower transverse member 175′ is orientedto traverse an elongated slot 252 in the elongated channel 14″ of theend effector 12″. A disengagement slot (not shown) is also provide dinthe anvil 20″ such that when the knife bar 172′ has been driven to anending position with thin end effector 12″, the upper transverse member173′ drops through the corresponding slot to enable the anvil 20″ tomove to the open position to disengage the stapled and cut tissue. Theanvil 20″ may be otherwise identical to anvil 20 described above and theelongated channel 14″ may be otherwise identical to elongated channel 14described above.

In these embodiments, the anvil 20″ is biased to a fully open position(FIG. 2) by a spring or other opening arrangement (not shown). The anvil20″ is moved between the open and fully clamped positions by the axialtravel of the firing adapter 150 in the manner described above. Once thefiring adapter 150 has been advanced to the fully clamped position (FIG.3), the surgeon may then advance the knife bar 172″ distally in themanner described above. If the surgeon desires to use the end effectoras a grasping device to manipulate tissue, the firing adapter may bemoved proximally to allow the anvil 20″ to move away from the elongatedchannel 14″ as represented in FIG. 4 in broken lines. In thisembodiment, as the knife bar 172″ moves distally, the upper transversemember 173′ and the lower transverse member 175′ draw the anvil 20″ andelongated channel 14″ together to achieve the desired staple formationas the knife bar 172″ is advanced distally through the end effector 12″.See FIG. 5. Thus, in this embodiment, staple formation occurssimultaneously with tissue cutting, but the staples themselves may besequentially formed as the knife bar 172″ is driven distally.

The unique and novel features of the various surgical staple cartridgesand the surgical instruments of the present invention enable the staplesin those cartridges to be arranged in one or more linear or non-linearlines. A plurality of such staple lines may be provided on each side ofan elongated slot that is centrally disposed within the staple cartridgefor receiving the tissue cutting member therethrough. In onearrangement, for example, the staples in one line may be substantiallyparallel with the staples in adjacent line(s) of staples, but offsettherefrom. In still other embodiments, one or more lines of staples maybe non-linear in nature. That is, the base of at least one staple in aline of staples may extend along an axis that is substantiallytransverse to the bases of other staples in the same staple line. Forexample, the lines of staples on each side of the elongated slot mayhave a zigzag appearance.

In various embodiments, a staple cartridge can comprise a cartridge bodyand a plurality of staples stored within the cartridge body. In use, thestaple cartridge can be introduced into a surgical site and positionedon a side of the tissue being treated. In addition, a staple-forminganvil can be positioned on the opposite side of the tissue. In variousembodiments, the anvil can be carried by a first jaw and the staplecartridge can be carried by a second jaw, wherein the first jaw and/orthe second jaw can be moved toward the other. Once the staple cartridgeand the anvil have been positioned relative to the tissue, the staplescan be ejected from the staple cartridge body such that the staples canpierce the tissue and contact the staple-forming anvil. Once the stapleshave been deployed from the staple cartridge body, the staple cartridgebody can then be removed from the surgical site. In various embodimentsdisclosed herein, a staple cartridge, or at least a portion of a staplecartridge, can be implanted with the staples. In at least one suchembodiment, as described in greater detail further below, a staplecartridge can comprise a cartridge body which can be compressed,crushed, and/or collapsed by the anvil when the anvil is moved from anopen position into a closed position. When the cartridge body iscompressed, crushed, and/or collapsed, the staples positioned within thecartridge body can be deformed by the anvil. Alternatively, the jawsupporting the staple cartridge can be moved toward the anvil into aclosed position. In either event, in various embodiments, the staplescan be deformed while they are at least partially positioned within thecartridge body. In certain embodiments, the staples may not be ejectedfrom the staple cartridge while, in some embodiments, the staples can beejected from the staple cartridge along with a portion of the cartridgebody.

Referring now to FIGS. 6A-6D, a compressible staple cartridge, such asstaple cartridge 1000, for example, can comprise a compressible,implantable cartridge body 1010 and, in addition, a plurality of staples1020 positioned in the compressible cartridge body 1010, although onlyone staple 1020 is depicted in FIGS. 6A-6D. FIG. 6A illustrates thestaple cartridge 1000 supported by a staple cartridge support, or staplecartridge channel, 1030, wherein the staple cartridge 1000 isillustrated in an uncompressed condition. In such an uncompressedcondition, the anvil 1040 may or may not be in contact with the tissueT. In use, the anvil 1040 can be moved from an open position intocontact with the tissue T as illustrated in FIG. 6B and position thetissue T against the cartridge body 1010. Even though the anvil 1040 canposition the tissue T against a tissue-contacting surface 1019 of staplecartridge body 1010, referring again to FIG. 6B, the staple cartridgebody 1010 may be subjected to little, if any, compressive force orpressure at such point and the staples 1020 may remain in an unformed,or unfired, condition. As illustrated in FIGS. 6A and 6B, the staplecartridge body 1010 can comprise one or more layers and the staple legs1021 of staples 1020 can extend upwardly through these layers. Invarious embodiments, the cartridge body 1010 can comprise a first layer1011, a second layer 1012, a third layer 1013, wherein the second layer1012 can be positioned intermediate the first layer 1011 and the thirdlayer 1013, and a fourth layer 1014, wherein the third layer 1013 can bepositioned intermediate the second layer 1012 and the fourth layer 1014.In at least one embodiment, the bases 1022 of the staples 1020 can bepositioned within cavities 1015 in the fourth layer 1014 and the staplelegs 1021 can extend upwardly from the bases 1022 and through the fourthlayer 1014, the third layer 1013, and the second layer 1012, forexample. In various embodiments, each deformable leg 1021 can comprise atip, such as sharp tip 1023, for example, which can be positioned in thesecond layer 1012, for example, when the staple cartridge 1000 is in anuncompressed condition. In at least one such embodiment, the tips 1023may not extend into and/or through the first layer 1011, wherein, in atleast one embodiment, the tips 1023 may not protrude through thetissue-contacting surface 1019 when the staple cartridge 1000 is in anuncompressed condition. In certain other embodiments, the sharp tips1023 may be positioned in the third layer 1013, and/or any othersuitable layer, when the staple cartridge is in an uncompressedcondition. In various alternative embodiments, a cartridge body of astaple cartridge may have any suitable number of layers such as lessthan four layers or more than four layers, for example.

In various embodiments, as described in greater detail below, the firstlayer 1011 can be comprised of a buttress material and/or plasticmaterial, such as polydioxanone (PDS) and/or polyglycolic acid (PGA),for example, and the second layer 1012 can be comprised of abioabsorbable foam material and/or a compressible haemostatic material,such as oxidized regenerated cellulose (ORC), for example. In variousembodiments, one or more of the first layer 1011, the second layer 1012,the third layer 1013, and the fourth layer 1014 may hold the staples1020 within the staple cartridge body 1010 and, in addition, maintainthe staples 1020 in alignment with one another. In various embodiments,the third layer 1013 can be comprised of a buttress material, or afairly incompressible or inelastic material, which can be configured tohold the staple legs 1021 of the staples 1020 in position relative toone another. Furthermore, the second layer 1012 and the fourth layer1014, which are positioned on opposite sides of the third layer 1013,can stabilize, or reduce the movement of, the staples 1020 even thoughthe second layer 1012 and the fourth layer 1014 can be comprised of acompressible foam or elastic material. In certain embodiments, thestaple tips 1023 of the staple legs 1021 can be at least partiallyembedded in the first layer 1011. In at least one such embodiment, thefirst layer 1011 and the third layer 1013 can be configured toco-operatively and firmly hold the staple legs 1021 in position. In atleast one embodiment, the first layer 1011 and the third layer 1013 caneach be comprised of a sheet of bioabsorbable plastic, such aspolyglycolic acid (PGA) which is marketed under the trade name Vicryl,polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate(PHA), poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example, and the second layer 1012 and thefourth layer 1014 can each be comprised of at least one haemostaticmaterial or agent.

Although the first layer 1011 can be compressible, the second layer 1012can be substantially more compressible than the first layer 1011. Forexample, the second layer 1012 can be about twice as compressible, aboutthree times as compressible, about four times as compressible, aboutfive times as compressible, and/or about ten times as compressible, forexample, as the first layer 1011. Stated another way, the second layer1012 may compress about two times, about three times, about four times,about five times, and/or about ten times as much as first layer 1011,for a given force. In certain embodiments, the second layer 1012 can bebetween about twice as compressible and about ten times as compressible,for example, as the first layer 1011. In at least one embodiment, thesecond layer 1012 can comprise a plurality of air voids defined therein,wherein the amount and/or size of the air voids in the second layer 1012can be controlled in order to provide a desired compressibility of thesecond layer 1012. Similar to the above, although the third layer 1013can be compressible, the fourth layer 1014 can be substantially morecompressible than the third layer 1013. For example, the fourth layer1014 can be about twice as compressible, about three times ascompressible, about four times as compressible, about five times ascompressible, and/or about ten times as compressible, for example, asthe third layer 1013. Stated another way, the fourth layer 1014 maycompress about two times, about three times, about four times, aboutfive times, and/or about ten times as much as third layer 1013, for agiven force. In certain embodiments, the fourth layer 1014 can bebetween about twice as compressible and about ten times as compressible,for example, as the third layer 1013. In at least one embodiment, thefourth layer 1014 can comprise a plurality of air voids defined therein,wherein the amount and/or size of the air voids in the fourth layer 1014can be controlled in order to provide a desired compressibility of thefourth layer 1014. In various circumstances, the compressibility of acartridge body, or cartridge body layer, can be expressed in terms of acompression rate, i.e., a distance in which a layer is compressed for agiven amount of force. For example, a layer having a high compressionrate will compress a larger distance for a given amount of compressiveforce applied to the layer as compared to a layer having a lowercompression rate. This being said, the second layer 1012 can have ahigher compression rate than the first layer 1011 and, similarly, thefourth layer 1014 can have a higher compression rate than the thirdlayer 1013. In various embodiments, the second layer 1012 and the fourthlayer 1014 can be comprised of the same material and can comprise thesame compression rate. In various embodiments, the second layer 1012 andthe fourth layer 1014 can be comprised of materials having differentcompression rates. Similarly, the first layer 1011 and the third layer1013 can be comprised of the same material and can comprise the samecompression rate. In certain embodiments, the first layer 1011 and thethird layer 1013 can be comprised of materials having differentcompression rates.

As the anvil 1040 is moved toward its closed position, the anvil 1040can contact tissue T and apply a compressive force to the tissue T andthe staple cartridge 1000, as illustrated in FIG. 6C. In suchcircumstances, the anvil 1040 can push the top surface, ortissue-contacting surface 1019, of the cartridge body 1010 downwardlytoward the staple cartridge support 1030. In various embodiments, thestaple cartridge support 1030 can comprise a cartridge support surface1031 which can be configured to support the staple cartridge 1000 as thestaple cartridge 1000 is compressed between the cartridge supportsurface 1031 and the tissue-contacting surface 1041 of anvil 1040. Owingto the pressure applied by the anvil 1040, the cartridge body 1010 canbe compressed and the anvil 1040 can come into contact with the staples1020. More particularly, in various embodiments, the compression of thecartridge body 1010 and the downward movement of the tissue-contactingsurface 1019 can cause the tips 1023 of the staple legs 1021 to piercethe first layer 1011 of cartridge body 1010, pierce the tissue T, andenter into forming pockets 1042 in the anvil 1040. As the cartridge body1010 is further compressed by the anvil 1040, the tips 1023 can contactthe walls defining the forming pockets 1042 and, as a result, the legs1021 can be deformed or curled inwardly, for example, as illustrated inFIG. 6C. As the staple legs 1021 are being deformed, as also illustratedin FIG. 6C, the bases 1022 of the staples 1020 can be in contact with orsupported by the staple cartridge support 1030. In various embodiments,as described in greater detail below, the staple cartridge support 1030can comprise a plurality of support features, such as staple supportgrooves, slots, or troughs 1032, for example, which can be configured tosupport the staples 1020, or at least the bases 1022 of the staples1020, as the staples 1020 are being deformed. As also illustrated inFIG. 6C, the cavities 1015 in the fourth layer 1014 can collapse as aresult of the compressive force applied to the staple cartridge body1010. In addition to the cavities 1015, the staple cartridge body 1010can further comprise one or more voids, such as voids 1016, for example,which may or may not comprise a portion of a staple positioned therein,that can be configured to allow the cartridge body 1010 to collapse. Invarious embodiments, the cavities 1015 and/or the voids 1016 can beconfigured to collapse such that the walls defining the cavities and/orwalls deflect downwardly and contact the cartridge support surface 1031and/or contact a layer of the cartridge body 1010 positioned underneaththe cavities and/or voids.

Upon comparing FIG. 6B and FIG. 6C, it is evident that the second layer1012 and the fourth layer 1014 have been substantially compressed by thecompressive pressure applied by the anvil 1040. It may also be notedthat the first layer 1011 and the third layer 1013 have been compressedas well. As the anvil 1040 is moved into its closed position, the anvil1040 may continue to further compress the cartridge body 1010 by pushingthe tissue-contacting surface 1019 downwardly toward the staplecartridge support 1030. As the cartridge body 1010 is furthercompressed, the anvil 1040 can deform the staples 1020 into theircompletely-formed shape as illustrated in FIG. 6D. Referring to FIG. 6D,the legs 1021 of each staple 1020 can be deformed downwardly toward thebase 1022 of each staple 1020 in order to capture at least a portion ofthe tissue T, the first layer 1011, the second layer 1012, the thirdlayer 1013, and the fourth layer 1014 between the deformable legs 1021and the base 1022. Upon comparing FIGS. 6C and 6D, it is further evidentthat the second layer 1012 and the fourth layer 1014 have been furthersubstantially compressed by the compressive pressure applied by theanvil 1040. It may also be noted upon comparing FIGS. 6C and 6D that thefirst layer 1011 and the third layer 1013 have been further compressedas well. After the staples 1020 have been completely, or at leastsufficiently, formed, the anvil 1040 can be lifted away from the tissueT and the staple cartridge support 1030 can be moved away, and/ordetached from, the staple cartridge 1000. As depicted in FIG. 6D, and asa result of the above, the cartridge body 1010 can be implanted with thestaples 1020. In various circumstances, the implanted cartridge body1010 can support the tissue along the staple line. In somecircumstances, a haemostatic agent, and/or any other suitabletherapeutic medicament, contained within the implanted cartridge body1010 can treat the tissue over time. A haemostatic agent, as mentionedabove, can reduce the bleeding of the stapled and/or incised tissuewhile a bonding agent or tissue adhesive can provide strength to thetissue over time. The implanted cartridge body 1010 can be comprised ofmaterials such as ORC (oxidized regenerated cellulose), extracellularproteins such as collagen, polyglycolic acid (PGA) which is marketedunder the trade name Vicryl, polylactic acid (PLA or PLLA),polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) which is marketed under the trade name Monocryl, polycaprolactone(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, forexample. In certain circumstances, the cartridge body 1010 can comprisean antibiotic and/or anti-microbial material, such as colloidal silverand/or triclosan, for example, which can reduce the possibility ofinfection in the surgical site.

In various embodiments, the layers of the cartridge body 1010 can beconnected to one another. In at least one embodiment, the second layer1012 can be adhered to the first layer 1011, the third layer 1013 can beadhered to the second layer 1012, and the fourth layer 1014 can beadhered to the third layer 1013 utilizing at least one adhesive, such asfibrin and/or protein hydrogel, for example. In certain embodiments,although not illustrated, the layers of the cartridge body 1010 can beconnected together by interlocking mechanical features. In at least onesuch embodiment, the first layer 1011 and the second layer 1012 can eachcomprise corresponding interlocking features, such as a tongue andgroove arrangement and/or a dovetail joint arrangement, for example.Similarly, the second layer 1012 and the third layer 1013 can eachcomprise corresponding interlocking features while the third layer 1013and the fourth layer 1014 can each comprise corresponding interlockingfeatures. In certain embodiments, although not illustrated, the staplecartridge 1000 can comprise one or more rivets, for example, which canextend through one or more layers of the cartridge body 1010. In atleast one such embodiment, each rivet can comprise a first end, or head,positioned adjacent to the first layer 1011 and a second head positionedadjacent to the fourth layer 1014 which can be either assembled to orformed by a second end of the rivet. Owing to the compressible nature ofthe cartridge body 1010, in at least one embodiment, the rivets cancompress the cartridge body 1010 such that the heads of the rivets canbe recessed relative to the tissue-contacting surface 1019 and/or thebottom surface 1018 of the cartridge body 1010, for example. In at leastone such embodiment, the rivets can be comprised of a bioabsorbablematerial, such as polyglycolic acid (PGA) which is marketed under thetrade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketedunder the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example. Incertain embodiments, the layers of the cartridge body 1010 may not beconnected to one another other than by the staples 1020 containedtherein. In at least one such embodiment, the frictional engagementbetween the staple legs 1021 and the cartridge body 1010, for example,can hold the layers of the cartridge body 1010 together and, once thestaples have been formed, the layers can be captured within the staples1020. In certain embodiments, at least a portion of the staple legs 1021can comprise a roughened surface or rough coating which can increase thefriction forces between the staples 1020 and the cartridge body 1010.

As described above, a surgical instrument can comprise a first jawincluding the staple cartridge support 1030 and a second jaw includingthe anvil 1040. In various embodiments, as described in greater detailfurther below, the staple cartridge 1000 can comprise one or moreretention features which can be configured to engage the staplecartridge support 1030 and, as a result, releasably retain the staplecartridge 1000 to the staple cartridge support 1030. In certainembodiments, the staple cartridge 1000 can be adhered to the staplecartridge support 1030 by at least one adhesive, such as fibrin and/orprotein hydrogel, for example. In use, in at least one circumstance,especially in laparoscopic and/or endoscopic surgery, the second jaw canbe moved into a closed position opposite the first jaw, for example,such that the first and second jaws can be inserted through a trocarinto a surgical site. In at least one such embodiment, the trocar candefine an approximately 5 mm aperture, or cannula, through which thefirst and second jaws can be inserted. In certain embodiments, thesecond jaw can be moved into a partially-closed position intermediatethe open position and the closed position which can allow the first andsecond jaws to be inserted through the trocar without deforming thestaples 1020 contained in the staple cartridge body 1010. In at leastone such embodiment, the anvil 1040 may not apply a compressive force tothe staple cartridge body 1010 when the second jaw is in itspartially-closed intermediate position while, in certain otherembodiments, the anvil 1040 can compress the staple cartridge body 1010when the second jaw is in its partially-closed intermediate position.Even though the anvil 1040 can compress the staple cartridge body 1010when it is in such an intermediate position, the anvil 1040 may notsufficiently compress the staple cartridge body 1010 such that the anvil1040 comes into contact with the staples 1020 and/or such that thestaples 1020 are deformed by the anvil 1040. Once the first and secondjaws have been inserted through the trocar into the surgical site, thesecond jaw can be opened once again and the anvil 1040 and the staplecartridge 1000 can be positioned relative to the targeted tissue asdescribed above.

In various embodiments, referring now to FIGS. 7A-7D, an end effector ofa surgical stapler can comprise an implantable staple cartridge 1100positioned intermediate an anvil 1140 and a staple cartridge support1130. Similar to the above, the anvil 1140 can comprise atissue-contacting surface 1141, the staple cartridge 1100 can comprise atissue-contacting surface 1119, and the staple cartridge support 1130can comprise a support surface 1131 which can be configured to supportthe staple cartridge 1100. Referring to FIG. 7A, the anvil 1140 can beutilized to position the tissue T against the tissue contacting surface1119 of staple cartridge 1100 without deforming the staple cartridge1100 and, when the anvil 1140 is in such a position, thetissue-contacting surface 1141 can be positioned a distance 1101 a awayfrom the staple cartridge support surface 1131 and the tissue-contactingsurface 1119 can be positioned a distance 1102 a away from the staplecartridge support surface 1131. Thereafter, as the anvil 1140 is movedtoward the staple cartridge support 1130, referring now to FIG. 7B, theanvil 1140 can push the top surface, or tissue-contacting surface 1119,of staple cartridge 1100 downwardly and compress the first layer 1111and the second layer 1112 of cartridge body 1110. As the layers 1111 and1112 are compressed, referring again to FIG. 7B, the second layer 1112can be crushed and the legs 1121 of staples 1120 can pierce the firstlayer 1111 and enter into the tissue T. In at least one such embodiment,the staples 1120 can be at least partially positioned within staplecavities, or voids, 1115 in the second layer 1112 and, when the secondlayer 1112 is compressed, the staple cavities 1115 can collapse and, asa result, allow the second layer 1112 to collapse around the staples1120. In various embodiments, the second layer 1112 can comprise coverportions 1116 which can extend over the staple cavities 1115 andenclose, or at least partially enclose, the staple cavities 1115. FIG.7B illustrates the cover portions 1116 being crushed downwardly into thestaple cavities 1115. In certain embodiments, the second layer 1112 cancomprise one or more weakened portions which can facilitate the collapseof the second layer 1112. In various embodiments, such weakened portionscan comprise score marks, perforations, and/or thin cross-sections, forexample, which can facilitate a controlled collapse of the cartridgebody 1110. In at least one embodiment, the first layer 1111 can compriseone or more weakened portions which can facilitate the penetration ofthe staple legs 1121 through the first layer 1111. In variousembodiments, such weakened portions can comprise score marks,perforations, and/or thin cross-sections, for example, which can bealigned, or at least substantially aligned, with the staple legs 1121.

When the anvil 1140 is in a partially closed, unfired position,referring again to FIG. 7A, the anvil 1140 can be positioned a distance1101 a away from the cartridge support surface 1131 such that a gap isdefined therebetween. This gap can be filled by the staple cartridge1100, having a staple cartridge height 1102 a, and the tissue T. As theanvil 1140 is moved downwardly to compress the staple cartridge 1100,referring again to FIG. 7B, the distance between the tissue contactingsurface 1141 and the cartridge support surface 1131 can be defined by adistance 1101 b which is shorter than the distance 1101 a. In variouscircumstances, the gap between the tissue-contacting surface 1141 ofanvil 1140 and the cartridge support surface 1131, defined by distance1101 b, may be larger than the original, undeformed staple cartridgeheight 1102 a. As the anvil 1140 is moved closer to the cartridgesupport surface 1131, referring now to FIG. 7C, the second layer 1112can continue to collapse and the distance between the staple legs 1121and the forming pockets 1142 can decrease. Similarly, the distancebetween the tissue-contacting surface 1141 and the cartridge supportsurface 1131 can decrease to a distance 1101 c which, in variousembodiments, may be greater than, equal to, or less than the original,undeformed cartridge height 1102 a. Referring now to FIG. 7D, the anvil1140 can be moved into a final, fired position in which the staples 1120have been fully formed, or at least formed to a desired height. In sucha position, the tissue-contacting surface 1141 of anvil 1140 can be adistance 1101 d away from the cartridge support surface 1131, whereinthe distance 1101 d can be shorter than the original, undeformedcartridge height 1102 a. As also illustrated in FIG. 7D, the staplecavities 1115 may be fully, or at least substantially, collapsed and thestaples 1120 may be completely, or at least substantially, surrounded bythe collapsed second layer 1112. In various circumstances, the anvil1140 can be thereafter moved away from the staple cartridge 1100. Oncethe anvil 1140 has been disengaged from the staple cartridge 1100, thecartridge body 1110 can at least partially re-expand in variouslocations, i.e., locations intermediate adjacent staples 1120, forexample. In at least one embodiment, the crushed cartridge body 1110 maynot resiliently re-expand. In various embodiments, the formed staples1120 and, in addition, the cartridge body 1110 positioned intermediateadjacent staples 1120 may apply pressure, or compressive forces, to thetissue T which may provide various therapeutic benefits.

As discussed above, referring again to the embodiment illustrated inFIG. 7A, each staple 1120 can comprise staple legs 1121 extendingtherefrom. Although staples 1120 are depicted as comprising two staplelegs 1121, various staples can be utilized which can comprise one stapleleg or, alternatively, more than two staple legs, such as three staplelegs or four staple legs, for example. As illustrated in FIG. 7A, eachstaple leg 1121 can be embedded in the second layer 1112 of thecartridge body 1110 such that the staples 1120 are secured within thesecond layer 1112. In various embodiments, the staples 1120 can beinserted into the staple cavities 1115 in cartridge body 1110 such thatthe tips 1123 of the staple legs 1121 enter into the cavities 1115before the bases 1122. After the tips 1123 have been inserted into thecavities 1115, in various embodiments, the tips 1123 can be pressed intothe cover portions 1116 and incise the second layer 1112. In variousembodiments, the staples 1120 can be seated to a sufficient depth withinthe second layer 1112 such that the staples 1120 do not move, or atleast substantially move, relative to the second layer 1112. In certainembodiments, the staples 1120 can be seated to a sufficient depth withinthe second layer 1112 such that the bases 1122 are positioned orembedded within the staple cavities 1115. In various other embodiments,the bases 1122 may not be positioned or embedded within the second layer1112. In certain embodiments, referring again to FIG. 7A, the bases 1122may extend below the bottom surface 1118 of the cartridge body 1110. Incertain embodiments, the bases 1122 can rest on, or can be directlypositioned against, the cartridge support surface 1130. In variousembodiments, the cartridge support surface 1130 can comprise supportfeatures extending therefrom and/or defined therein wherein, in at leastone such embodiment, the bases 1122 of the staples 1120 may bepositioned within and supported by one or more support grooves, slots,or troughs, 1132, for example, in the staple cartridge support 1130, asdescribed in greater detail further below.

In various embodiments, referring now to FIGS. 8 and 9, a staplecartridge, such as staple cartridge 1200, for example, can comprise acompressible, implantable cartridge body 1210 comprising an outer layer1211 and an inner layer 1212. Similar to the above, the staple cartridge1200 can comprise a plurality of staples 1220 positioned within thecartridge body 1210. In various embodiments, each staple 1220 cancomprise a base 1222 and one or more staple legs 1221 extendingtherefrom. In at least one such embodiment, the staple legs 1221 can beinserted into the inner layer 1212 and seated to a depth in which thebases 1222 of the staples 1220 abut and/or are positioned adjacent tothe bottom surface 1218 of the inner layer 1212, for example. In theembodiment depicted in FIGS. 8 and 9, the inner layer 1212 does notcomprise staple cavities configured to receive a portion of the staples1220 while, in other embodiments, the inner layer 1212 can comprise suchstaple cavities. In various embodiments, further to the above, the innerlayer 1212 can be comprised of a compressible material, such asbioabsorbable foam and/or oxidized regenerated cellulose (ORC), forexample, which can be configured to allow the cartridge body 1210 tocollapse when a compressive load is applied thereto. In variousembodiments, the inner layer 1212 can be comprised of a lyophilized foamcomprising polylactic acid (PLA) and/or polyglycolic acid (PGA), forexample. The ORC may be commercially available under the trade nameSurgicel and can comprise a loose woven fabric (like a surgical sponge),loose fibers (like a cotton ball), and/or a foam. In at least oneembodiment, the inner layer 1212 can be comprised of a materialincluding medicaments, such as freeze-dried thrombin and/or fibrin, forexample, contained therein and/or coated thereon which can bewater-activated and/or activated by fluids within the patient's body,for example. In at least one such embodiment, the freeze-dried thrombinand/or fibrin can be held on a Vicryl (PGA) matrix, for example. Incertain circumstances, however, the activatable medicaments can beunintentionally activated when the staple cartridge 1200 is insertedinto a surgical site within the patient, for example. In variousembodiments, referring again to FIGS. 8 and 9, the outer layer 1211 canbe comprised of a water impermeable, or at least substantially waterimpermeable, material such that liquids do not come into contact with,or at least substantially contact, the inner layer 1212 until after thecartridge body 1210 has been compressed and the staple legs havepenetrated the outer layer 1211 and/or after the outer layer 1211 hasbeen incised in some fashion. In various embodiments, the outer layer1211 can be comprised of a buttress material and/or plastic material,such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.In certain embodiments, the outer layer 1211 can comprise a wrap whichsurrounds the inner layer 1212 and the staples 1220. More particularly,in at least one embodiment, the staples 1220 can be inserted into theinner layer 1212 and the outer layer 1211 can be wrapped around thesub-assembly comprising the inner layer 1212 and the staples 1220 andthen sealed.

In various embodiments described herein, the staples of a staplecartridge can be fully formed by an anvil when the anvil is moved into aclosed position. In various other embodiments, referring now to FIGS.10-13, the staples of a staple cartridge, such as staple cartridge 4100,for example, can be deformed by an anvil when the anvil is moved into aclosed position and, in addition, by a staple driver system which movesthe staples toward the closed anvil. The staple cartridge 4100 cancomprise a compressible cartridge body 4110 which can be comprised of afoam material, for example, and a plurality of staples 4120 at leastpartially positioned within the compressible cartridge body 4110. Invarious embodiments, the staple driver system can comprise a driverholder 4160, a plurality of staple drivers 4162 positioned within thedriver holder 4160, and a staple cartridge pan 4180 which can beconfigured to retain the staple drivers 4162 in the driver holder 4160.In at least one such embodiment, the staple drivers 4162 can bepositioned within one or more slots 4163 in the driver holder 4160wherein the sidewalls of the slots 4163 can assist in guiding the stapledrivers 4162 upwardly toward the anvil. In various embodiments, thestaples 4120 can be supported within the slots 4163 by the stapledrivers 4162 wherein, in at least one embodiment, the staples 4120 canbe entirely positioned in the slots 4163 when the staples 4120 and thestaple drivers 4162 are in their unfired positions. In certain otherembodiments, at least a portion of the staples 4120 can extend upwardlythrough the open ends 4161 of slots 4163 when the staples 4120 andstaple drivers 4162 are in their unfired positions. In at least one suchembodiment, referring primarily now to FIG. 11, the bases of the staples4120 can be positioned within the driver holder 4160 and the tips of thestaples 4120 can be embedded within the compressible cartridge body4110. In certain embodiments, approximately one-third of the height ofthe staples 4120 can be positioned within the driver holder 4160 andapproximately two-thirds of the height of the staples 4120 can bepositioned within the cartridge body 4110. In at least one embodiment,referring to FIG. 10A, the staple cartridge 4100 can further comprise awater impermeable wrap or membrane 4111 surrounding the cartridge body4110 and the driver holder 4160, for example.

In use, the staple cartridge 4100 can be positioned within a staplecartridge channel, for example, and the anvil can be moved toward thestaple cartridge 4100 into a closed position. In various embodiments,the anvil can contact and compress the compressible cartridge body 4110when the anvil is moved into its closed position. In certainembodiments, the anvil may not contact the staples 4120 when the anvilis in its closed position. In certain other embodiments, the anvil maycontact the legs of the staples 4120 and at least partially deform thestaples 4120 when the anvil is moved into its closed position. In eitherevent, the staple cartridge 4100 can further comprise one or more sleds4170 which can be advanced longitudinally within the staple cartridge4100 such that the sleds 4170 can sequentially engage the staple drivers4162 and move the staple drivers 4162 and the staples 4120 toward theanvil. In various embodiments, the sleds 4170 can slide between thestaple cartridge pan 4180 and the staple drivers 4162. In embodimentswhere the closure of the anvil has started the forming process of thestaples 4120, the upward movement of the staples 4120 toward the anvilcan complete the forming process and deform the staples 4120 to theirfully formed, or at least desired, height. In embodiments where theclosure of the anvil has not deformed the staples 4120, the upwardmovement of the staples 4120 toward the anvil can initiate and completethe forming process and deform the staples 4120 to their fully formed,or at least desired, height. In various embodiments, the sleds 4170 canbe advanced from a proximal end of the staple cartridge 4100 to a distalend of the staple cartridge 4100 such that the staples 4120 positionedin the proximal end of the staple cartridge 4100 are fully formed beforethe staples 4120 positioned in the distal end of the staple cartridge4100 are fully formed. In at least one embodiment, referring to FIG. 12,the sleds 4170 can each comprise at least one angled or inclined surface4711 which can be configured to slide underneath the staple drivers 4162and lift the staple drivers 4162 as illustrated in FIG. 13.

In various embodiments, further to the above, the staples 4120 can beformed in order to capture at least a portion of the tissue T and atleast a portion of the compressible cartridge body 4110 of the staplecartridge 4100 therein. After the staples 4120 have been formed, theanvil and the staple cartridge channel 4130 of the surgical stapler canbe moved away from the implanted staple cartridge 4100. In variouscircumstances, the cartridge pan 4180 can be fixedly engaged with thestaple cartridge channel 4130 wherein, as a result, the cartridge pan4180 can become detached from the compressible cartridge body 4110 asthe staple cartridge channel 4130 is pulled away from the implantedcartridge body 4110. In various embodiments, referring again to FIG. 10,the cartridge pan 4180 can comprise opposing side walls 4181 betweenwhich the cartridge body 4110 can be removably positioned. In at leastone such embodiment, the compressible cartridge body 4110 can becompressed between the side walls 4181 such that the cartridge body 4110can be removably retained therebetween during use and releasablydisengaged from the cartridge pan 4180 as the cartridge pan 4180 ispulled away. In at least one such embodiment, the driver holder 4160 canbe connected to the cartridge pan 4180 such that the driver holder 4160,the drivers 4162, and/or the sleds 4170 can remain in the cartridge pan4180 when the cartridge pan 4180 is removed from the surgical site. Incertain other embodiments, the drivers 4162 can be ejected from thedriver holder 4160 and left within the surgical site. In at least onesuch embodiment, the drivers 4162 can be comprised of a bioabsorbablematerial, such as polyglycolic acid (PGA) which is marketed under thetrade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketedunder the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example. Invarious embodiments, the drivers 4162 can be attached to the staples4120 such that the drivers 4162 are deployed with the staples 4120. Inat least one such embodiment, each driver 4162 can comprise a troughconfigured to receive the bases of the staples 4120, for example,wherein, in at least one embodiment, the troughs can be configured toreceive the staple bases in a press-fit and/or snap-fit manner.

In certain embodiments, further to the above, the driver holder 4160and/or the sleds 4170 can be ejected from the cartridge pan 4180. In atleast one such embodiment, the sleds 4170 can slide between thecartridge pan 4180 and the driver holder 4160 such that, as the sleds4170 are advanced in order to drive the staple drivers 4162 and staples4120 upwardly, the sleds 4170 can move the driver holder 4160 upwardlyout of the cartridge pan 4180 as well. In at least one such embodiment,the driver holder 4160 and/or the sleds 4170 can be comprised of abioabsorbable material, such as polyglycolic acid (PGA) which ismarketed under the trade name Vicryl, polylactic acid (PLA or PLLA),polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) which is marketed under the trade name Monocryl, polycaprolactone(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, forexample. In various embodiments, the sleds 4170 can be integrally formedand/or attached to a drive bar, or cutting member, which pushes thesleds 4170 through the staple cartridge 4100. In such embodiments, thesleds 4170 may not be ejected from the cartridge pan 4180 and may remainwith the surgical stapler while, in other embodiments in which the sleds4170 are not attached to the drive bar, the sleds 4170 may be left inthe surgical site. In any event, further to the above, thecompressibility of the cartridge body 4110 can allow thicker staplecartridges to be used within an end effector of a surgical stapler asthe cartridge body 4110 can compress, or shrink, when the anvil of thestapler is closed. In certain embodiments, as a result of the staplesbeing at least partially deformed upon the closure of the anvil, tallerstaples, such as staples having an approximately 0.18″ staple height,for example, could be used, wherein approximately 0.12″ of the stapleheight can be positioned within the compressible layer 4110 and whereinthe compressible layer 4110 can have an uncompressed height ofapproximately 0.14″, for example.

In many embodiments described herein, a staple cartridge can comprise aplurality of staples therein. In various embodiments, such staples canbe comprised of a metal wire deformed into a substantially U-shapedconfiguration having two staple legs. Other embodiments are envisionedin which staples can comprise different configurations such as two ormore wires that have been joined together having three or more staplelegs. In various embodiments, the wire, or wires, used to form thestaples can comprise a round, or at least substantially round,cross-section. In at least one embodiment, the staple wires can compriseany other suitable cross-section, such as square and/or rectangularcross-sections, for example. In certain embodiments, the staples can becomprised of plastic wires. In at least one embodiment, the staples canbe comprised of plastic-coated metal wires. In various embodiments, acartridge can comprise any suitable type of fastener in addition to orin lieu of staples. In at least one such embodiment, such a fastener cancomprise pivotable arms which are folded when engaged by an anvil. Incertain embodiments, two-part fasteners could be utilized. In at leastone such embodiment, a staple cartridge can comprise a plurality offirst fastener portions and an anvil can comprise a plurality of secondfastener portions which are connected to the first fastener portionswhen the anvil is compressed against the staple cartridge. In certainembodiments, as described above, a sled or driver can be advanced withina staple cartridge in order to complete the forming process of thestaples. In certain embodiments, a sled or driver can be advanced withinan anvil in order to move one or more forming members downwardly intoengagement with the opposing staple cartridge and the staples, orfasteners, positioned therein.

In various embodiments described herein, a staple cartridge can comprisefour rows of staples stored therein. In at least one embodiment, thefour staple rows can be arranged in two inner staple rows and two outerstaple rows. In at least one such embodiment, an inner staple row and anouter staple row can be positioned on a first side of a cutting member,or knife, slot within the staple cartridge and, similarly, an innerstaple row and an outer staple row can be positioned on a second side ofthe cutting member, or knife, slot. In certain embodiments, a staplecartridge may not comprise a cutting member slot; however, such a staplecartridge may comprise a designated portion configured to be incised bya cutting member in lieu of a staple cartridge slot. In variousembodiments, the inner staple rows can be arranged within the staplecartridge such that they are equally, or at least substantially equally,spaced from the cutting member slot. Similarly, the outer staple rowscan be arranged within the staple cartridge such that they are equally,or at least substantially equally, spaced from the cutting member slot.In various embodiments, a staple cartridge can comprise more than orless than four rows of staples stored within a staple cartridge. In atleast one embodiment, a staple cartridge can comprise six rows ofstaples. In at least one such embodiment, the staple cartridge cancomprise three rows of staples on a first side of a cutting member slotand three rows of staples on a second side of the cutting member slot.In certain embodiments, a staple cartridge may comprise an odd number ofstaple rows. For example, a staple cartridge may comprise two rows ofstaples on a first side of a cutting member slot and three rows ofstaples on a second side of the cutting member slot. In variousembodiments, the staple rows can comprise staples having the same, or atleast substantially the same, unformed staple height. In certain otherembodiments, one or more of the staple rows can comprise staples havinga different unformed staple height than the other staples. In at leastone such embodiment, the staples on a first side of a cutting memberslot may have a first unformed height and the staples on a second sideof a cutting member slot may have a second unformed height which isdifferent than the first height, for example.

In various embodiments, as described above, a staple cartridge cancomprise a cartridge body including a plurality of staple cavitiesdefined therein. The cartridge body can comprise a deck and a top decksurface wherein each staple cavity can define an opening in the decksurface. As also described above, a staple can be positioned within eachstaple cavity such that the staples are stored within the cartridge bodyuntil they are ejected therefrom. Prior to being ejected from thecartridge body, in various embodiments, the staples can be containedwith the cartridge body such that the staples do not protrude above thedeck surface. As the staples are positioned below the deck surface, insuch embodiments, the possibility of the staples becoming damaged and/orprematurely contacting the targeted tissue can be reduced. In variouscircumstances, the staples can be moved between an unfired position inwhich they do not protrude from the cartridge body and a fired positionin which they have emerged from the cartridge body and can contact ananvil positioned opposite the staple cartridge. In various embodiments,the anvil, and/or the forming pockets defined within the anvil, can bepositioned a predetermined distance above the deck surface such that, asthe staples are being deployed from the cartridge body, the staples aredeformed to a predetermined formed height. In some circumstances, thethickness of the tissue captured between the anvil and the staplecartridge may vary and, as a result, thicker tissue may be capturedwithin certain staples while thinner tissue may be captured withincertain other staples. In either event, the clamping pressure, or force,applied to the tissue by the staples may vary from staple to staple orvary between a staple on one end of a staple row and a staple on theother end of the staple row, for example. In certain circumstances, thegap between the anvil and the staple cartridge deck can be controlledsuch that the staples apply a certain minimum clamping pressure withineach staple. In some such circumstances, however, significant variationof the clamping pressure within different staples may still exist.Surgical stapling instruments are disclosed in U.S. Pat. No. 7,380,696,which issued on Jun. 3, 2008, the entire disclosure of which isincorporated by reference herein. An illustrative multi-stroke handlefor the surgical stapling and severing instrument is described ingreater detail in the co-pending and co-owned U.S. patent applicationentitled SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRINGPOSITION INDICATOR AND RETRACTION MECHANISM, Ser. No. 10/374,026, thedisclosure of which is hereby incorporated by reference in its entirety.Other applications consistent with the present invention may incorporatea single firing stroke, such as described in co-pending and commonlyowned U.S. patent application SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, Ser. No. 10/441,632, thedisclosure of which is hereby incorporated by reference in its entirety.

In various embodiments described herein, a staple cartridge can comprisemeans for compensating for the thickness of the tissue captured withinthe staples deployed from the staple cartridge. In various embodiments,referring to FIG. 14, a staple cartridge, such as staple cartridge10000, for example, can include a rigid first portion, such as supportportion 10010, for example, and a compressible second portion, such astissue thickness compensator 10020, for example. In at least oneembodiment, referring primarily to FIG. 16, the support portion 10010can comprise a cartridge body, a top deck surface 10011, and a pluralityof staple cavities 10012 wherein, similar to the above, each staplecavity 10012 can define an opening in the deck surface 10011. A staple10030, for example, can be removably positioned in each staple cavity10012. In at least one such embodiment, each staple 10030 can comprise abase 10031 and one or more legs 10032 extending from the base 10031.Prior to the staples 10030 being deployed, as also described in greaterdetail below, the bases 10031 of the staples 10030 can be supported bystaple drivers positioned within the support portion 10010 and,concurrently, the legs 10032 of the staples 10030 can be at leastpartially contained within the staple cavities 10012. In variousembodiments, the staples 10030 can be deployed between an unfiredposition and a fired position such that the legs 10032 move through thetissue thickness compensator 10020, penetrate through a top surface ofthe tissue thickness compensator 10020, penetrate the tissue T, andcontact an anvil positioned opposite the staple cartridge 10000. As thelegs 10032 are deformed against the anvil, the legs 10032 of each staple10030 can capture a portion of the tissue thickness compensator 10020and a portion of the tissue T within each staple 10030 and apply acompressive force to the tissue. Further to the above, the legs 10032 ofeach staple 10030 can be deformed downwardly toward the base 10031 ofthe staple to form a staple entrapment area 10039 in which the tissue Tand the tissue thickness compensator 10020 can be captured. In variouscircumstances, the staple entrapment area 10039 can be defined betweenthe inner surfaces of the deformed legs 10032 and the inner surface ofthe base 10031. The size of the entrapment area for a staple can dependon several factors such as the length of the legs, the diameter of thelegs, the width of the base, and/or the extent in which the legs aredeformed, for example.

In previous embodiments, a surgeon was often required to select theappropriate staples having the appropriate staple height for the tissuebeing stapled. For example, a surgeon could select tall staples for usewith thick tissue and short staples for use with thin tissue. In somecircumstances, however, the tissue being stapled did not have aconsistent thickness and, thus, some staples were unable to achieve thedesired fired configuration. For example, FIG. 48 illustrates a tallstaple used in thin tissue. Referring now to FIG. 49, when a tissuethickness compensator, such as tissue thickness compensator 10020, forexample, is used with thin tissue, for example, the larger staple may beformed to a desired fired configuration.

Owing to the compressibility of the tissue thickness compensator, thetissue thickness compensator can compensate for the thickness of thetissue captured within each staple. More particularly, referring now toFIGS. 43 and 44, a tissue thickness compensator, such as tissuethickness compensator 10020, for example, can consume larger and/orsmaller portions of the staple entrapment area 10039 of each staple10030 depending on the thickness and/or type of tissue contained withinthe staple entrapment area 10039. For example, if thinner tissue T iscaptured within a staple 10030, the tissue thickness compensator 10020can consume a larger portion of the staple entrapment area 10039 ascompared to circumstances where thicker tissue T is captured within thestaple 10030. Correspondingly, if thicker tissue T is captured within astaple 10030, the tissue thickness compensator 10020 can consume asmaller portion of the staple entrapment area 10039 as compared to thecircumstances where thinner tissue T is captured within the staple10030. In this way, the tissue thickness compensator can compensate forthinner tissue and/or thicker tissue and assure that a compressivepressure is applied to the tissue irrespective, or at leastsubstantially irrespective, of the tissue thickness captured within thestaples. In addition to the above, the tissue thickness compensator10020 can compensate for different types, or compressibilities, oftissues captured within different staples 10030. Referring now to FIG.44, the tissue thickness compensator 10020 can apply a compressive forceto vascular tissue T which can include vessels V and, as a result,restrict the flow of blood through the less compressible vessels V whilestill applying a desired compressive pressure to the surrounding tissueT. In various circumstances, further to the above, the tissue thicknesscompensator 10020 can also compensate for malformed staples. Referringto FIG. 45, the malformation of various staples 10030 can result inlarger staple entrapment areas 10039 being defined within such staples.Owing to the resiliency of the tissue thickness compensator 10020,referring now to FIG. 46, the tissue thickness compensator 10020positioned within malformed staples 10030 may still apply a sufficientcompressive pressure to the tissue T eventhough the staple entrapmentareas 10039 defined within such malformed staples 10030 may be enlarged.In various circumstances, the tissue thickness compensator 10020 locatedintermediate adjacent staples 10030 can be biased against the tissue Tby properly-formed staples 10030 surrounding a malformed staple 10030and, as a result, apply a compressive pressure to the tissue surroundingand/or captured within the malformed staple 10030, for example. Invarious circumstances, a tissue thickness compensator can compensate fordifferent tissue densities which can arise due to calcifications,fibrous areas, and/or tissue that has been previously stapled ortreated, for example.

In various embodiments, a fixed, or unchangeable, tissue gap can bedefined between the support portion and the anvil and, as a result, thestaples may be deformed to a predetermined height regardless of thethickness of the tissue captured within the staples. When a tissuethickness compensator is used with these embodiments, the tissuethickness compensator can adapt to the tissue captured between the anviland the support portion staple cartridge and, owing to the resiliency ofthe tissue thickness compensator, the tissue thickness compensator canapply an additional compressive pressure to the tissue. Referring now toFIGS. 50-55, a staple 10030 has been formed to a predefined height H.With regard to FIG. 50, a tissue thickness compensator has not beenutilized and the tissue T consumes the entirety of the staple entrapmentarea 10039. With regard to FIG. 57, a portion of a tissue thicknesscompensator 10020 has been captured within the staple 10030, compressedthe tissue T, and consumed at least a portion of the staple entrapmentarea 10039. Referring now to FIG. 52, thin tissue T has been capturedwithin the staple 10030. In this embodiment, the compressed tissue T hasa height of approximately 2/9H and the compressed tissue thicknesscompensator 10020 has a height of approximately 7/9H, for example.Referring now to FIG. 53, tissue T having an intermediate thickness hasbeen captured within the staple 10030. In this embodiment, thecompressed tissue T has a height of approximately 4/9H and thecompressed tissue thickness compensator 10020 has a height ofapproximately 5/9H, for example. Referring now to FIG. 54, tissue Thaving an intermediate thickness has been captured within the staple10030. In this embodiment, the compressed tissue T has a height ofapproximately ⅔H and the compressed tissue thickness compensator 10020has a height of approximately ⅓H, for example. Referring now to FIG. 53,thick tissue T has been captured within the staple 10030. In thisembodiment, the compressed tissue T has a height of approximately 8/9Hand the compressed tissue thickness compensator 10020 has a height ofapproximately 1/9H, for example. In various circumstances, the tissuethickness compensator can comprise a compressed height which comprisesapproximately 10% of the staple entrapment height, approximately 20% ofthe staple entrapment height, approximately 30% of the staple entrapmentheight, approximately 40% of the staple entrapment height, approximately50% of the staple entrapment height, approximately 60% of the stapleentrapment height, approximately 70% of the staple entrapment height,approximately 80% of the staple entrapment height, and/or approximately90% of the staple entrapment height, for example.

In various embodiments, the staples 10030 can comprise any suitableunformed height. In certain embodiments, the staples 10030 can comprisean unformed height between approximately 2 mm and approximately 4.8 mm,for example. The staples 10030 can comprise an unformed height ofapproximately 2.0 mm, approximately 2.5 mm, approximately 3.0 mm,approximately 3.4 mm, approximately 3.5 mm, approximately 3.8 mm,approximately 4.0 mm, approximately 4.1 mm, and/or approximately 4.8 mm,for example. In various embodiments, the height H to which the staplescan be deformed can be dictated by the distance between the deck surface10011 of the support portion 10010 and the opposing anvil. In at leastone embodiment, the distance between the deck surface 10011 and thetissue-contacting surface of the anvil can be approximately 0.097″, forexample. The height H can also be dictated by the depth of the formingpockets defined within the anvil. In at least one embodiment, theforming pockets can have a depth measured from the tissue-contactingsurface, for example. In various embodiments, as described in greaterdetail below, the staple cartridge 10000 can further comprise stapledrivers which can lift the staples 10030 toward the anvil and, in atleast one embodiment, lift, or “overdrive”, the staples above the decksurface 10011. In such embodiments, the height H to which the staples10030 are formed can also be dictated by the distance in which thestaples 10030 are overdriven. In at least one such embodiment, thestaples 10030 can be overdriven by approximately 0.028″, for example,and can result in the staples 10030 being formed to a height ofapproximately 0.189″, for example. In various embodiments, the staples10030 can be formed to a height of approximately 0.8 mm, approximately1.0 mm, approximately 1.5 mm, approximately 1.8 mm, approximately 2.0mm, and/or approximately 2.25 mm, for example. In certain embodiments,the staples can be formed to a height between approximately 2.25 mm andapproximately 3.0 mm, for example. Further to the above, the height ofthe staple entrapment area of a staple can be determined by the formedheight of the staple and the width, or diameter, of the wire comprisingthe staple. In various embodiments, the height of the staple entrapmentarea 10039 of a staple 10030 can comprise the formed height H of thestaple less two diameter widths of the wire. In certain embodiments, thestaple wire can comprise a diameter of approximately 0.0089″, forexample. In various embodiments, the staple wire can comprise a diameterbetween approximately 0.0069″ and approximately 0.0119″, for example. Inat least one exemplary embodiment, the formed height H of a staple 10030can be approximately 0.189″ and the staple wire diameter can beapproximately 0.0089″ resulting in a staple entrapment height ofapproximately 0.171″, for example.

In various embodiments, further to the above, the tissue thicknesscompensator can comprise an uncompressed, or pre-deployed, height andcan be configured to deform to one of a plurality of compressed heights.In certain embodiments, the tissue thickness compensator can comprise anuncompressed height of approximately 0.125″, for example. In variousembodiments, the tissue thickness compensator can comprise anuncompressed height of greater than or equal to approximately 0.080″,for example. In at least one embodiment, the tissue thicknesscompensator can comprise an uncompressed, or pre-deployed, height whichis greater than the unfired height of the staples. In at least oneembodiment, the uncompressed, or pre-deployed, height of the tissuethickness compensator can be approximately 10% taller, approximately 20%taller, approximately 30% taller, approximately 40% taller,approximately 50% taller, approximately 60% taller, approximately 70%taller, approximately 80% taller, approximately 90% taller, and/orapproximately 100% taller than the unfired height of the staples, forexample. In at least one embodiment, the uncompressed, or pre-deployed,height of the tissue thickness compensator can be up to approximately100% taller than the unfired height of the staples, for example. Incertain embodiments, the uncompressed, or pre-deployed, height of thetissue thickness compensator can be over 100% taller than the unfiredheight of the staples, for example. In at least one embodiment, thetissue thickness compensator can comprise an uncompressed height whichis equal to the unfired height of the staples. In at least oneembodiment, the tissue thickness compensator can comprise anuncompressed height which is less than the unfired height of thestaples. In at least one embodiment, the uncompressed, or pre-deployed,height of the thickness compensator can be approximately 10% shorter,approximately 20% shorter, approximately 30% shorter, approximately 40%shorter, approximately 50% shorter, approximately 60% shorter,approximately 70% shorter, approximately 80% shorter, and/orapproximately 90% shorter than the unfired height of the staples, forexample. In various embodiments, the compressible second portion cancomprise an uncompressed height which is taller than an uncompressedheight of the tissue T being stapled. In certain embodiments, the tissuethickness compensator can comprise an uncompressed height which is equalto an uncompressed height of the tissue T being stapled. In variousembodiments, the tissue thickness compensator can comprise anuncompressed height which is shorter than an uncompressed height of thetissue T being stapled.

As described above, a tissue thickness compensator can be compressedwithin a plurality of formed staples regardless of whether thick tissueor thin tissue is captured within the staples. In at least one exemplaryembodiment, the staples within a staple line, or row, can be deformedsuch that the staple entrapment area of each staple comprises a heightof approximately 2.0 mm, for example, wherein the tissue T and thetissue thickness compensator can be compressed within this height. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 1.75 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately0.25 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 1.50 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately0.50 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 1.25 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately0.75 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 1.0 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately1.0 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 0.75 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately1.25 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 1.50 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately0.50 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example. Incertain circumstances, the tissue T can comprise a compressed height ofapproximately 0.25 mm within the staple entrapment area while the tissuethickness compensator can comprise a compressed height of approximately1.75 mm within the staple entrapment area, thereby totaling theapproximately 2.0 mm staple entrapment area height, for example.

In various embodiments, further to the above, the tissue thicknesscompensator can comprise an uncompressed height which is less than thefired height of the staples. In certain embodiments, the tissuethickness compensator can comprise an uncompressed height which is equalto the fired height of the staples. In certain other embodiments, thetissue thickness compensator can comprise an uncompressed height whichis taller than the fired height of the staples. In at least one suchembodiment, the uncompressed height of a tissue thickness compensatorcan comprise a thickness which is approximately 110% of the formedstaple height, approximately 120% of the formed staple height,approximately 130% of the formed staple height, approximately 140% ofthe formed staple height, approximately 150% of the formed stapleheight, approximately 160% of the formed staple height, approximately170% of the formed staple height, approximately 180% of the formedstaple height, approximately 190% of the formed staple height, and/orapproximately 200% of the formed staple height, for example. In certainembodiments, the tissue thickness compensator can comprise anuncompressed height which is more than twice the fired height of thestaples. In various embodiments, the tissue thickness compensator cancomprise a compressed height which is from approximately 85% toapproximately 150% of the formed staple height, for example. In variousembodiments, as described above, the tissue thickness compensator can becompressed between an uncompressed thickness and a compressed thickness.In certain embodiments, the compressed thickness of a tissue thicknesscompensator can be approximately 10% of its uncompressed thickness,approximately 20% of its uncompressed thickness, approximately 30% ofits uncompressed thickness, approximately 40% of its uncompressedthickness, approximately 50% of its uncompressed thickness,approximately 60% of its uncompressed thickness, approximately 70% ofits uncompressed thickness, approximately 80% of its uncompressedthickness, and/or approximately 90% of its uncompressed thickness, forexample. In various embodiments, the uncompressed thickness of thetissue thickness compensator can be approximately two times,approximately ten times, approximately fifty times, and/or approximatelyone hundred times thicker than its compressed thickness, for example. Inat least one embodiment, the compressed thickness of the tissuethickness compensator can be between approximately 60% and approximately99% of its uncompressed thickness. In at least one embodiment, theuncompressed thickness of the tissue thickness compensator can be atleast 50% thicker than its compressed thickness. In at least oneembodiment, the uncompressed thickness of the tissue thicknesscompensator can be up to one hundred times thicker than its compressedthickness. In various embodiments, the compressible second portion canbe elastic, or at least partially elastic, and can bias the tissue Tagainst the deformed legs of the staples. In at least one suchembodiment, the compressible second portion can resiliently expandbetween the tissue T and the base of the staple in order to push thetissue T against the legs of the staple. In certain embodiments,discussed in further detail below, the tissue thickness compensator canbe positioned intermediate the tissue T and the deformed staple legs. Invarious circumstances, as a result of the above, the tissue thicknesscompensator can be configured to consume any gaps within the stapleentrapment area.

In various embodiments, the tissue thickness compensator may comprisematerials characterized by one or more of the following properties:biocompatible, bioabsorable, bioresorbable, biodurable, biodegradable,compressible, fluid absorbable, swellable, self-expandable, bioactive,medicament, pharmaceutically active, anti-adhesion, haemostatic,antibiotic, anti-microbial, anti-viral, nutritional, adhesive,permeable, hydrophilic and/or hydrophobic, for example. In variousembodiments, a surgical instrument comprising an anvil and a staplecartridge may comprise a tissue thickness compensator associated withthe anvil and/or staple cartridge comprising at least one of ahaemostatic agent, such as fibrin and thrombin, an antibiotic, such asdoxycpl, and mendicant, such as matrix metalloproteinases (MMPs).

In various embodiments, the tissue thickness compensator may comprisesynthetic and/or non-synthetic materials. The tissue thicknesscompensator may comprise a polymeric composition comprising one or moresynthetic polymers and/or one or more non-synthetic polymers. Thesynthetic polymer may comprise a synthetic absorbable polymer and/or asynthetic non-absorbable polymer. In various embodiments, the polymericcomposition may comprise a biocompatible foam, for example. Thebiocompatible foam may comprise a porous, open cell foam and/or aporous, closed cell foam, for example. The biocompatible foam may have auniform pore morphology or may have a gradient pore morphology (i.e.small pores gradually increasing in size to large pores across thethickness of the foam in one direction). In various embodiments, thepolymeric composition may comprise one or more of a porous scaffold, aporous matrix, a gel matrix, a hydrogel matrix, a solution matrix, afilamentous matrix, a tubular matrix, a composite matrix, a membranousmatrix, a biostable polymer, and a biodegradable polymer, andcombinations thereof. For example, the tissue thickness compensator maycomprise a foam reinforced by a filamentous matrix or may comprise afoam having an additional hydrogel layer that expands in the presence ofbodily fluids to further provide the compression on the tissue. Invarious embodiments, a tissue thickness compensator could also becomprised of a coating on a material and/or a second or third layer thatexpands in the presence of bodily fluids to further provide thecompression on the tissue. Such a layer could be a hydrogel that couldbe a synthetic and/or naturally derived material and could be eitherbiodurable and/or biodegradable, for example. In various embodiments,the tissue thickness compensator may comprise a microgel or a nanogel.The hydrogel may comprise carbohydrate-derived microgels and/ornanogels. In certain embodiments, a tissue thickness compensator may bereinforced with fibrous non-woven materials or fibrous mesh typeelements, for example, that can provide additional flexibility,stiffness, and/or strength. In various embodiments, a tissue thicknesscompensator that has a porous morphology which exhibits a gradientstructure such as, for example, small pores on one surface and largerpores on the other surface. Such morphology could be more optimal fortissue in-growth or haemostatic behavior. Further, the gradient could bealso compositional with a varying bio-absorption profile. A short termabsorption profile may be preferred to address hemostasis while a longterm absorption profile may address better tissue healing withoutleakages.

Examples of non-synthetic materials include, but are not limited to,lyophilized polysaccharide, glycoprotein, bovine pericardium, collagen,gelatin, fibrin, fibrinogen, elastin, proteoglycan, keratin, albumin,hydroxyethyl cellulose, cellulose, oxidized cellulose, oxidizedregenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethylcellulose, carboxymethylcellulose, chitan, chitosan, casein, alginate,and combinations thereof.

Examples of synthetic absorbable materials include, but are not limitedto, poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA),polycaprolactone (PCL), polyglycolic acid (PGA), poly(trimethylenecarbonate) (TMC), polyethylene terephthalate (PET), polyhydroxyalkanoate(PHA), a copolymer of glycolide and ε-caprolactone (PGCL), a copolymerof glycolide and-trimethylene carbonate, poly(glycerol sebacate) (PGS),poly(dioxanone) (PDS), polyesters, poly(orthoesters), polyoxaesters,polyetheresters, polycarbonates, polyamide esters, polyanhydrides,polysaccharides, poly(ester-amides), tyrosine-based polyarylates,polyamines, tyrosine-based polyiminocarbonates, tyrosine-basedpolycarbonates, poly(D,L-lactide-urethane), poly(hydroxybutyrate),poly(B-hydroxybutyrate), poly(E-caprolactone), polyethyleneglycol (PEG),poly[bis(carboxylatophenoxy)phosphazene]poly(amino acids),pseudo-poly(amino acids), absorbable polyurethanes, poly (phosphazine),polyphosphazenes, polyalkyleneoxides, polyacrylamides,polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinylalcohols, poly(caprolactone), polyacrylic acid, polyacetate,polypropylene, aliphatic polyesters, glycerols, copoly(ether-esters),polyalkylene oxalates, polyamides, poly(iminocarbonates), polyalkyleneoxalates, and combinations thereof. In various embodiments, thepolyester is may be selected from the group consisting of polylactides,polyglycolides, trimethylene carbonates, polydioxanones,polycaprolactones, polybutesters, and combinations thereof.

In various embodiments, the synthetic absorbable polymer may compriseone or more of 90/10 poly(glycolide-L-lactide) copolymer, commerciallyavailable from Ethicon, Inc. under the trade designation VICRYL(polyglactic 910), polyglycolide, commercially available from AmericanCyanamid Co. under the trade designation DEXON, polydioxanone,commercially available from Ethicon, Inc. under the trade designationPDS, poly(glycolide-trimethylene carbonate) random block copolymer,commercially available from American Cyanamid Co. under the tradedesignation MAXON, 75/25poly(glycolide-ε-caprolactone-poliglecaprolactone 25) copolymer,commercially available from Ethicon under the trade designationMONOCRYL, for example.

Examples of synthetic non-absorbable materials include, but are notlimited to, polyurethane, polypropylene (PP), polyethylene (PE),polycarbonate, polyamides, such as nylon, polyvinylchloride (PVC),polymethylmetacrylate (PMMA), polystyrene (PS), polyester,polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE),polytrifluorochloroethylene (PTFCE), polyvinylfluoride (PVF),fluorinated ethylene propylene (FEP), polyacetal, polysulfone, silicons,and combinations thereof. The synthetic non-absorbable polymers mayinclude, but are not limited to, foamed elastomers and porouselastomers, such as, for example, silicone, polyisoprene, and rubber. Invarious embodiments, the synthetic polymers may comprise expandedpolytetrafluoroethylene (ePTFE), commercially available from W. L. Gore& Associates, Inc. under the trade designation GORE-TEX Soft TissuePatch and co-polyetherester urethane foam commercially available fromPolyganics under the trade designation NASOPORE.

In various embodiments, the polymeric composition may comprise fromapproximately 50% to approximately 90% by weight of the polymericcomposition of PLLA and approximately 50% to approximately 10% by weightof the polymeric composition of PCL, for example. In at least oneembodiment, the polymeric composition may comprise approximately 70% byweight of PLLA and approximately 30% by weight of PCL, for example. Invarious embodiments, the polymeric composition may comprise fromapproximately 55% to approximately 85% by weight of the polymericcomposition of PGA and 15% to 45% by weight of the polymeric compositionof PCL, for example. In at least one embodiment, the polymericcomposition may comprise approximately 65% by weight of PGA andapproximately 35% by weight of PCL, for example. In various embodiments,the polymeric composition may comprise from approximately 90% toapproximately 95% by weight of the polymeric composition of PGA andapproximately 5% to approximately 10% by weight of the polymericcomposition of PLA, for example.

In various embodiments, the synthetic absorbable polymer may comprise abioabsorbable, biocompatible elastomeric copolymer. Suitablebioabsorbable, biocompatible elastomeric copolymers include but are notlimited to copolymers of ε-caprolactone and glycolide (preferably havinga mole ratio of ε-caprolactone to glycolide of from about 30:70 to about70:30, preferably 35:65 to about 65:35, and more preferably 45:55 to35:65); elastomeric copolymers of ε-caprolactone and lactide, includingL-lactide, D-lactide blends thereof or lactic acid copolymers(preferably having a mole ratio of ε-caprolactone to lactide of fromabout 35:65 to about 65:35 and more preferably 45:55 to 30:70)elastomeric copolymers of p-dioxanone (1,4-dioxan-2-one) and lactideincluding L-lactide, D-lactide and lactic acid (preferably having a moleratio of p-dioxanone to lactide of from about 40:60 to about 60:40);elastomeric copolymers of ε-caprolactone and p-dioxanone (preferablyhaving a mole ratio of ε-caprolactone to p-dioxanone of from about 30:70to about 70:30); elastomeric copolymers of p-dioxanone and trimethylenecarbonate (preferably having a mole ratio of p-dioxanone to trimethylenecarbonate of from about 30:70 to about 70:30); elastomeric copolymers oftrimethylene carbonate and glycolide (preferably having a mole ratio oftrimethylene carbonate to glycolide of from about 30:70 to about 70:30);elastomeric copolymer of trimethylene carbonate and lactide includingL-lactide, D-lactide, blends thereof or lactic acid copolymers(preferably having a mole ratio of trimethylene carbonate to lactide offrom about 30:70 to about 70:30) and blends thereof. In one embodiment,the elastomeric copolymer is a copolymer of glycolide andε-caprolactone. In another embodiment, the elastomeric copolymer is acopolymer of lactide and ε-caprolactone.

The disclosures of U.S. Pat. No. 5,468,253, entitled ELASTOMERIC MEDICALDEVICE, which issued on Nov. 21, 1995, and U.S. Pat. No. 6,325,810,entitled FOAM BUTTRESS FOR STAPLING APPARATUS, which issued on Dec. 4,2001, are hereby incorporated by reference in their respectiveentireties.

In various embodiments, the tissue thickness compensator may comprise anemulsifier. Examples of emulsifiers may include, but are not limited to,water-soluble polymers, such as, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol(PPG), PLURONICS, TWEENS, polysaccharides and combinations thereof.

In various embodiments, the tissue thickness compensator may comprise asurfactant. Examples of surfactants may include, but are not limited to,polyacrylic acid, methalose, methyl cellulose, ethyl cellulose, propylcellulose, hydroxy ethyl cellulose, carboxy methyl cellulose,polyoxyethylene cetyl ether, polyoxyethylene lauryl ether,polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether,polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate,polyoxyethylene stearyl ether, polyoxyethylene nonylphenyl ether,dialkylphenoxy poly(ethyleneoxy) ethanol, and polyoxamers.

In various embodiments, the polymeric composition may comprise apharmaceutically active agent. The polymeric composition may release atherapeutically effective amount of the pharmaceutically active agent.In various embodiments, the pharmaceutically active agent may bereleased as the polymeric composition is desorbed/absorbed. In variousembodiments, the pharmaceutically active agent may be released intofluid, such as, for example, blood, passing over or through thepolymeric composition. Examples of pharmaceutically active agents mayinclude, but are not limited to, haemostatic agents and drugs, such as,for example, fibrin, thrombin, and oxidized regenerated cellulose (ORC);anti-inflammatory drugs, such as, for example, diclofenac, aspirin,naproxen, sulindac, and hydrocortisone; antibiotic and antimicrobialdrug or agents, such as, for example, triclosan, ionic silver,ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticanceragents, such as, for example, cisplatin, mitomycin, adriamycin.

In various embodiments, the polymeric composition may comprise ahaemostatic material. The tissue thickness compensator may comprisehaemostatic materials comprising poly(lactic acid), poly(glycolic acid),poly(hydroxybutyrate), poly(caprolactone), poly(dioxanone),polyalkyleneoxides, copoly(ether-esters), collagen, gelatin, thrombin,fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin,ovalbumin, polysaccharides, hyaluronic acid, chondroitin sulfate,hydroxyethyl starch, hydroxyethyl cellulose, cellulose, oxidizedcellulose, hydroxypropyl cellulose, carboxyethyl cellulose,carboxymethyl cellulose, chitan, chitosan, agarose, maltose,maltodextrin, alginate, clotting factors, methacrylate, polyurethanes,cyanoacrylates, platelet agonists, vasoconstrictors, alum, calcium, RGDpeptides, proteins, protamine sulfate, ε-amino caproic acid, ferricsulfate, ferric subsulfates, ferric chloride, zinc, zinc chloride,aluminum chloride, aluminum sulfates, aluminum acetates, permanganates,tannins, bone wax, polyethylene glycols, fucans and combinationsthereof. The tissue thickness compensator may be characterized byhaemostatic properties.

The polymeric composition of a tissue thickness compensator may becharacterized by percent porosity, pore size, and/or hardness, forexample. In various embodiments, the polymeric composition may have apercent porosity from approximately 30% by volume to approximately 99%by volume, for example. In certain embodiments, the polymericcomposition may have a percent porosity from approximately 60% by volumeto approximately 98% by volume, for example. In various embodiments, thepolymeric composition may have a percent porosity from approximately 85%by volume to approximately 97% by volume, for example. In at least oneembodiment, the polymeric composition may comprise approximately 70% byweight of PLLA and approximately 30% by weight of PCL, for example, andcan comprise approximately 90% porosity by volume, for example. In atleast one such embodiment, as a result, the polymeric composition wouldcomprise approximately 10% copolymer by volume. In at least oneembodiment, the polymeric composition may comprise approximately 65% byweight of PGA and approximately 35% by weight of PCL, for example, andcan have a percent porosity from approximately 93% by volume toapproximately 95% by volume, for example. In various embodiments, thepolymeric composition may comprise greater than 85% porosity by volume.The polymeric composition may have a pore size from approximately 5micrometers to approximately 2000 micrometers, for example. In variousembodiments, the polymeric composition may have a pore size betweenapproximately 10 micrometers to approximately 100 micrometers, forexample. In at least one such embodiment, the polymeric composition cancomprise a copolymer of PGA and PCL, for example. In certainembodiments, the polymeric composition may have a pore size betweenapproximately 100 micrometers to approximately 1000 micrometers, forexample. In at least one such embodiment, the polymeric composition cancomprise a copolymer of PLLA and PCL, for example.

According to certain aspects, the hardness of a polymeric compositionmay be expressed in terms of the Shore Hardness, which can defined asthe resistance to permanent indentation of a material as determined witha durometer, such as a Shore Durometer. In order to assess the durometervalue for a given material, a pressure is applied to the material with adurometer indenter foot in accordance with ASTM procedure D2240-00,entitled, “Standard Test Method for Rubber Property-Durometer Hardness”,the entirety of which is incorporated herein by reference. The durometerindenter foot may be applied to the material for a sufficient period oftime, such as 15 seconds, for example, wherein a reading is then takenfrom the appropriate scale. Depending on the type of scale being used, areading of 0 can be obtained when the indenter foot completelypenetrates the material, and a reading of 100 can be obtained when nopenetration into the material occurs. This reading is dimensionless. Invarious embodiments, the durometer may be determined in accordance withany suitable scale, such as Type A and/or Type OO scales, for example,in accordance with ASTM D2240-00. In various embodiments, the polymericcomposition of a tissue thickness compensator may have a Shore Ahardness value from approximately 4 A to approximately 16 A, forexample, which is approximately 45 OO to approximately 65 OO on theShore OO range. In at least one such embodiment, the polymericcomposition can comprise a PLLA/PCL copolymer or a PGA/PCL copolymer,for example. In various embodiments, the polymeric composition of atissue thickness compensator may have a Shore A Hardness value of lessthan 15 A. In various embodiments, the polymeric composition of a tissuethickness compensator may have a Shore A Hardness value of less than 10A. In various embodiments, the polymeric composition of a tissuethickness compensator may have a Shore A Hardness value of less than 5A. In certain embodiments, the polymeric material may have a Shore OOcomposition value from approximately 35 OO to approximately 75 OO, forexample.

In various embodiments, the polymeric composition may have at least twoof the above-identified properties. In various embodiments, thepolymeric composition may have at least three of the above-identifiedproperties. The polymeric composition may have a porosity from 85% to97% by volume, a pore size from 5 micrometers to 2000 micrometers, and aShore A hardness value from 4 A to 16 A and Shore OO hardness value from45 OO to 65 OO, for example. In at least one embodiment, the polymericcomposition may comprise 70% by weight of the polymeric composition ofPLLA and 30% by weight of the polymeric composition of PCL having aporosity of 90% by volume, a pore size from 100 micrometers to 1000micrometers, and a Shore A hardness value from 4 A to 16 A and Shore OOhardness value from 45 OO to 65 OO, for example. In at least oneembodiment, the polymeric composition may comprise 65% by weight of thepolymeric composition of PGA and 35% by weight of the polymericcomposition of PCL having a porosity from 93% to 95% by volume, a poresize from 10 micrometers to 100 micrometers, and a Shore A hardnessvalue from 4 A to 16 A and Shore OO hardness value from 45 OO to 65 OO,for example.

In various embodiments, the tissue thickness compensator may comprise amaterial that expands. As discussed above, the tissue thicknesscompensator may comprise a compressed material that expands whenuncompressed or deployed, for example. In various embodiments, thetissue thickness compensator may comprise a self-expanding materialformed in situ. In various embodiments, the tissue thickness compensatormay comprise at least one precursor selected to spontaneously crosslinkwhen contacted with at least one of other precursor(s), water, and/orbodily fluids. In various embodiments, a first precursor may contact oneor more other precursors to form an expandable and/or swellable tissuethickness compensator. In various embodiments, the tissue thicknesscompensator may comprise a fluid-swellable composition, such as awater-swellable composition, for example. In various embodiments, thetissue thickness compensator may comprise a gel comprising water.

In various embodiments, the tissue thickness compensator may comprise abiodegradable foam having an encapsulation comprising dry hydrogelparticles or granules embedded therein. Without wishing to be bound toany particular theory, the encapsulations in the foam may be formed bycontacting an aqueous solution of a hydrogel precursor and an organicsolution of biocompatible materials to form the foam. In variousembodiments, the aqueous solution and organic solution may formmicelles. The aqueous solution and organic solution may be dried toencapsulate dry hydrogel particles or granules within the foam. Forexample, a hydrogel precursor, such as a hydrophilic polymer, may bedissolved in water to form a dispersion of micelles. The aqueoussolution may contact an organic solution of dioxane comprisingpoly(glycolic acid) and polycaprolactone. The aqueous and organicsolutions may be lyophilized to form a biodegradable foam having dryhydrogel particles or granules dispersed therein. Without wishing to bebound to any particular theory, it is believed that the micelles formthe encapsulation having the dry hydrogel particles or granulesdispersed within the foam structure. In certain embodiments, theencapsulation may be ruptured, and the dry hydrogel particles orgranules may contact a fluid, such as a bodily fluid, and expand.

In various embodiments, as described above, the tissue thicknesscompensator may comprise an initial thickness and an expanded thickness.In certain embodiments, the initial thickness of a tissue thicknesscompensator can be approximately 0.001% of its expanded thickness,approximately 0.01% of its expanded thickness, approximately 0.1% of itsexpanded thickness, approximately 1% of its expanded thickness,approximately 10% of its expanded thickness, approximately 20% of itsexpanded thickness, approximately 30% of its expanded thickness,approximately 40% of its expanded thickness, approximately 50% of itsexpanded thickness, approximately 60% of its expanded thickness,approximately 70% of its expanded thickness, approximately 80% of itsexpanded thickness, and/or approximately 90% of its expanded thickness,for example. In various embodiments, the expanded thickness of thetissue thickness compensator can be approximately two times,approximately five times, approximately ten times, approximately fiftytimes, approximately one hundred times, approximately two hundred times,approximately three hundred times, approximately four hundred times,approximately five hundred times, approximately six hundred times,approximately seven hundred times, approximately eight hundred times,approximately nine hundred times, and/or approximately one thousandtimes thicker than its initial thickness, for example. In variousembodiments, the initial thickness of the tissue thickness compensatorcan be up to 1% its expanded thickness, up to 5% its expanded thickness,up to 10% its expanded thickness, and up to 50% its expanded thickness.In various embodiments, the expanded thickness of the tissue thicknesscompensator can be at least 50% thicker than its initial thickness, atleast 100% thicker than its initial thickness, at least 300% thickerthan its initial thickness, and at least 500% thicker than its initialthickness. As described above, in various circumstances, as a result ofthe above, the tissue thickness compensator can be configured to consumeany gaps within the staple entrapment area.

As discussed above, in various embodiments, the tissue thicknesscompensator may comprise a hydrogel. In various embodiments, thehydrogel may comprise homopolymer hydrogels, copolymer hydrogels,multipolymer hydrogels, interpenetrating polymer hydrogels, andcombinations thereof. In various embodiments, the hydrogel may comprisemicrogels, nanogels, and combinations thereof. The hydrogel maygenerally comprise a hydrophilic polymer network capable of absorbingand/or retaining fluids. In various embodiments, the hydrogel maycomprise a non-crosslinked hydrogel, a crosslinked hydrogel, andcombinations thereof. The hydrogel may comprise chemical crosslinks,physical crosslinks, hydrophobic segments and/or water insolublesegments. The hydrogel may be chemically crosslinked by polymerization,small-molecule crosslinking, and/or polymer-polymer crosslinking. Thehydrogel may be physically crosslinked by ionic interactions,hydrophobic interactions, hydrogen bonding interactions,sterocomplexation, and/or supramolecular chemistry. The hydrogel may besubstantially insoluble due to the crosslinks, hydrophobic segmentsand/or water insoluble segments, but be expandable and/or swellable dueto absorbing and/or retaining fluids. In certain embodiments, theprecursor may crosslink with endogenous materials and/or tissues.

In various embodiments, the hydrogel may comprise an environmentallysensitive hydrogel (ESH). The ESH may comprise materials havingfluid-swelling properties that relate to environmental conditions. Theenvironmental conditions may include, but are not limited to, thephysical conditions, biological conditions, and/or chemical conditionsat the surgical site. In various embodiments, the hydrogel may swell orshrink in response to temperature, pH, electric fields, ionic strength,enzymatic and/or chemical reactions, electrical and/or magnetic stimuli,and other physiological and environmental variables, for example. Invarious embodiments, the ESH may comprise multifunctional acrylates,hydroxyethylmethacrylate (HEMA), elastomeric acrylates, and relatedmonomers.

In various embodiments, the tissue thickness compensator comprising ahydrogel may comprise at least one of the non-synthetic materials andsynthetic materials described above. The hydrogel may comprise asynthetic hydrogel and/or a non-synthetic hydrogel. In variousembodiments, the tissue thickness compensator may comprise a pluralityof layers. The plurality of the layers may comprise porous layers and/ornon-porous layers. For example, the tissue thickness compensator maycomprise a non-porous layer and a porous layer. In another example, thetissue thickness compensator may comprise a porous layer intermediate afirst non-porous layer and a second non-porous layer. In anotherexample, the tissue thickness compensator may comprise a non-porouslayer intermediate a first porous layer and a second porous layer. Thenon-porous layers and porous layers may be positioned in any orderrelative to the surfaces of the staple cartridge and/or anvil.

Examples of the non-synthetic material may include, but are not limitedto, albumin, alginate, carbohydrate, casein, cellulose, chitin,chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen,gelatin, heparin, hyaluronic acid, keratin, protein, serum, and starch.The cellulose may comprise hydroxyethyl cellulose, oxidized cellulose,oxidized regenerated cellulose (ORC), hydroxypropyl cellulose,carboxyethyl cellulose, carboxymethylcellulose, and combinationsthereof. The collagen may comprise bovine pericardium. The carbohydratemay comprise a polysaccharide, such as lyophilized polysaccharide. Theprotein may comprise glycoprotein, proteoglycan, and combinationsthereof.

Examples of the synthetic material may include, but are not limited to,poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate),poly(phosphazine), polyesters, polyethylene glycols, polyethylene oxide,polyethylene oxide-co-polypropylene oxide, co-polyethylene oxide,polyalkyleneoxides, polyacrylamides, polyhydroxyethylmethylacrylate,poly(vinylpyrrolidone), polyvinyl alcohols, poly(caprolactone),poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, aliphaticpolyesters, glycerols, poly(amino acids), copoly(ether-esters),polyalkylene oxalates, polyamides, poly(iminocarbonates), polyoxaesters,polyorthoesters, polyphosphazenes and combinations thereof. In certainembodiments, the above non-synthetic materials may be syntheticallyprepared, e.g., synthetic hyaluronic acid, utilizing conventionalmethods.

In various embodiments, the hydrogel may be made from one or morehydrogel precursors. The precursor may comprise a monomer and/or amacromer. The hydrogel precursor may comprise an electrophile functionalgroup and/or a nucleophile electrophile functional group. In general,electrophiles may react with nucleophiles to form a bond. The term“functional group” as used herein refers to electrophilic ornucleophilic groups capable of reacting with each other to form a bond.Examples of electrophilic functional groups may include, but are notlimited to, N-hydroxysuccinimides (“NHS”), sulfosuccinimides,carbonyldiimidazole, sulfonyl chloride, aryl halides, sulfosuccinimidylesters, N-hydroxysuccinimidyl esters, succinimidyl esters such assuccinimidyl succinates and/or succinimidyl propionates, isocyanates,thiocyanates, carbodiimides, benzotriazole carbonates, epoxides,aldehydes, maleimides, imidoesters, combinations thereof, and the like.In at least one embodiment, the electrophilic functional group maycomprise a succinimidyl ester. Examples of nucleophile functional groupsmay include, but are not limited to, —NH₂, —SH, —OH, —PH₂, and—CO—NH—NH₂.

In various embodiments, the hydrogel may be formed from a singleprecursor or multiple precursors. In certain embodiments, the hydrogelmay be formed from a first precursor and a second precursor. The firsthydrogel precursor and second hydrogel precursor may form a hydrogel insitu and/or in vivo upon contact. The hydrogel precursor may generallyrefer to a polymer, functional group, macromolecule, small molecule,and/or crosslinker that can take part in a reaction to form a hydrogel.The precursor may comprise a homogeneous solution, heterogeneous, orphase separated solution in a suitable solvent, such as water or abuffer, for example. The buffer may have a pH from about 8 to about 12,such as, about 8.2 to about 9, for example. Examples of buffers mayinclude, but are not limited to borate buffers. In certain embodiments,the precursor(s) may be in an emulsion. In various embodiments, a firstprecursor may react with a second precursor to form a hydrogel. Invarious embodiments, the first precursor may spontaneously crosslinkwhen contacted with the second precursor. In various embodiments, afirst set of electrophilic functional groups on a first precursor mayreact with a second set of nucleophilic functional groups on a secondprecursor. When the precursors are mixed in an environment that permitsreaction (e.g., as relating to pH, temperature, and/or solvent), thefunctional groups may react with each other to form covalent bonds. Theprecursors may become crosslinked when at least some of the precursorsreact with more than one other precursor.

In various embodiments, the tissue thickness compensator may comprise atleast one monomer selected from the group consisting of 3-sulfopropylacrylate potassium salt (“KSPA”), sodium acrylate (“NaA”),N-(tris(hydroxylmethyl)methyl)acrylamide (“tris acryl”), and2-acrylamido-2-methyl-1-propane sulfonic acid (AMPS). The tissuethickness compensator may comprise a copolymer comprising two or moremonomers selected from the group consisting of KSPA, NaA, tris acryl,AMPS. The tissue thickness compensator may comprise homopolymers derivedfrom KSPA, NaA, trisacryl and AMPS. The tissue thickness compensator maycomprise hydrophilicity modifying monomers copolymerizable therewith.The hydrophilicity modifying monomers may comprise methylmethacrylate,butylacrylate, cyclohexylacrylate, styrene, styrene sulphonic acid.

In various embodiments, the tissue thickness compensator may comprise acrosslinker. The crosslinker may comprise a low molecular weight di- orpolyvinylic crosslinking agent, such as ethylenglycol diacrylate ordimethacrylate, di-, tri- or tetraethylen-glycol diacrylate ordimethacrylate, allyl (meth)acrylate, a C₂-C₈-alkylene diacrylate ordimethacrylate, divinyl ether, divinyl sulfone, di- and trivinylbenzene,trimethylolpropane triacrylate or trimethacrylate, pentaerythritoltetraacrylate or tetramethacrylate, bisphenol A diacrylate ordimethacrylate, methylene bisacrylamide or bismethacrylamide, ethylenebisacrylamide or ethylene bismethacrylamide, triallyl phthalate ordiallyl phthalate. In at least one embodiment, the crosslinker maycomprise N,N′-methylenebisacrylamide (“MBAA”).

In various embodiments, the tissue thickness compensator may comprise atleast one of acrylate and/or methacrylate functional hydrogels,biocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers, optionally comprising amine functional macromers,succinimidyl ester functional macromers, optionally comprising amineand/or sulfhydryl functional macromers, epoxy functional macromers,optionally comprising amine functional macromers, mixtures of proteinsand/or polypeptides and aldehyde crosslinkers, Genipin, andwater-soluble carbodiimides, anionic polysaccharides and polyvalentcations.

In various embodiments, the tissue thickness compensator may compriseunsaturated organic acid monomers, acrylic substituted alcohols, and/oracrylamides. In various embodiments, the tissue thickness compensatormay comprise methacrylic acids, acrylic acids, glycerolacrylate,glycerolmethacryulate, 2-hydroxyethylmethacrylate,2-hydroxyethylacrylate, 2-(dimethylaminoethyl) methacrylate, N-vinylpyrrolidone, methacrylamide, and/or N,N-dimethylacrylamidepoly(methacrylic acid).

In various embodiments, the tissue thickness compensator may comprise areinforcement material. In various embodiments, the reinforcementmaterial may comprise at least one of the non-synthetic materials andsynthetic materials described above. In various embodiments, thereinforcement material may comprise collagen, gelatin, fibrin,fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose,cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethylcellulose, carboxymethylcellulose, chitan, chitosan, alginate,poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate),poly(phosphazine), polyesters, polyethylene glycols, polyalkyleneoxides,polyacrylamides, polyhydroxyethylmethylacrylate, polyvinylpyrrolidone,polyvinyl alcohols, poly(caprolactone), poly(dioxanone), polyacrylicacid, polyacetate, polycaprolactone, polypropylene, aliphaticpolyesters, glycerols, poly(amino acids), copoly(ether-esters),polyalkylene oxalates, polyamides, poly(iminocarbonates), polyalkyleneoxalates, polyoxaesters, polyorthoesters, polyphosphazenes andcombinations thereof.

In various embodiments, the tissue thickness compensator may comprise alayer comprising the reinforcement material. In certain embodiments, aporous layer and/or a non-porous layer of a tissue thickness compensatormay comprise the reinforcement material. For example, the porous layermay comprise the reinforcement material and the non-porous layer may notcomprise the reinforcement material. In various embodiments, thereinforcement layer may comprise an inner layer intermediate a firstnon-porous layer and a second non-porous layer. In certain embodiments,the reinforcement layer may comprise an outer layer of the tissuethickness compensator. In certain embodiments, the reinforcement layermay comprise an exterior surface of the tissue thickness compensator.

In various embodiments, the reinforcement material may comprise meshes,monofilaments, multifilament braids, fibers, mats, felts, particles,and/or powders. In certain embodiments, the reinforcement material maybe incorporated into a layer of the tissue thickness compensator. Thereinforcement material may be incorporated into at least one of anon-porous layer and a porous layer. A mesh comprising the reinforcementmaterial may be formed using conventional techniques, such as, forexample, knitting, weaving, tatting, and/or knipling. In variousembodiments, a plurality of reinforcement materials may be oriented in arandom direction and/or a common direction. In certain embodiments, thecommon direction may be one of parallel to the staple line andperpendicular to the staple line, for example. For example, themonofilaments and/or multifilament braids may be oriented in a randomdirection and/or a common direction. The monofilaments and multifilamentbraids may be associated with the non-porous layer and/or the porouslayer. In various embodiments, the tissue thickness compensator maycomprise a plurality of reinforcement fibers oriented in a randomdirection within a non-porous layer. In various embodiments, the tissuethickness compensator may comprise a plurality of reinforcement fibersoriented in a common direction within a non-porous layer.

The fibers may form a non-woven material, such as, for example, a matand a felt. The fibers may have any suitable length, such as, forexample from 0.1 mm to 100 mm and 0.4 mm to 50 mm. The reinforcementmaterial may be ground to a powder. The powder may have a particle sizefrom 10 micrometers to 1 cm, for example. The powder may be incorporatedinto the tissue thickness compensator.

In various embodiments, the tissue thickness compensator may be formedin situ. In various embodiments, the hydrogel may be formed in situ. Thetissue thickness compensator may be formed in situ by covalent, ionic,and/or hydrophobic bonds. Physical (non-covalent) crosslinks may resultfrom complexation, hydrogen bonding, desolvation, Van der Waalsinteractions, ionic bonding, and combinations thereof. Chemical(covalent) crosslinking may be accomplished by any of a number ofmechanisms, including: free radical polymerization, condensationpolymerization, anionic or cationic polymerization, step growthpolymerization, electrophile-nucleophile reactions, and combinationsthereof.

In various embodiments, in situ formation of the tissue thicknesscompensator may comprise reacting two or more precursors that arephysically separated until contacted in situ and/or react to anenvironmental condition to react with each other to form the hydrogel.In situ polymerizable polymers may be prepared from precursor(s) thatcan be reacted to form a polymer at the surgical site. The tissuethickness compensator may be formed by crosslinking reactions of theprecursor(s) in situ. In certain embodiments, the precursor may comprisean initiator capable of initiating a polymerization reaction for theformation of the in situ tissue thickness compensator. The tissuethickness compensator may comprise a precursor that can be activated atthe time of application to create, in various embodiments, a crosslinkedhydrogel. In situ formation of the tissue thickness compensator maycomprise activating at least one precursor to form bonds to form thetissue thickness compensator. In various embodiments, activation may beachieved by changes in the physical conditions, biological conditions,and/or chemical conditions at the surgical site, including, but notlimited to temperature, pH, electric fields, ionic strength, enzymaticand/or chemical reactions, electrical and/or magnetic stimuli, and otherphysiological and environmental variables. In various embodiments, theprecursors may be contacted outside the body and introduced to thesurgical site.

In various embodiments, the tissue thickness compensator may compriseone or more encapsulations, or cells, which can be configured to storeat least one component therein. In certain embodiments, theencapsulation may be configured to store a hydrogel precursor therein.In certain embodiments, the encapsulation may be configured to store twocomponents therein, for example. In certain embodiments, theencapsulation may be configured to store a first hydrogel precursor anda second hydrogel precursor therein. In certain embodiments, a firstencapsulation may be configured to store a first hydrogel precursortherein and a second encapsulation may be configured to store a secondhydrogel precursor therein. As described above, the encapsulations canbe aligned, or at least substantially aligned, with the staple legs topuncture and/or otherwise rupture the encapsulations when the staplelegs contact the encapsulation. In certain embodiments, theencapsulations may be compressed, crushed, collapsed, and/or otherwiseruptured when the staples are deployed. After the encapsulations havebeen ruptured, the component(s) stored therein can flow out of theencapsulation. The component stored therein may contact othercomponents, layers of the tissue thickness compensator, and/or thetissue. In various embodiments, the other components may be flowing fromthe same or different encapsulations, provided in the layers of thetissue thickness compensator, and/or provided to the surgical site bythe clinician. As a result of the above, the component(s) stored withinthe encapsulations can provide expansion and/or swelling of the tissuethickness compensator.

In various embodiments, the tissue thickness compensator may comprise alayer comprising the encapsulations. In various embodiments, theencapsulation may comprise a void, a pocket, a dome, a tube, andcombinations thereof associated with the layer. In certain embodiments,the encapsulations may comprise voids in the layer. In at least oneembodiment, the layer can comprise two layers that can be attached toone another wherein the encapsulations can be defined between the twolayers. In certain embodiments, the encapsulations may comprise domes onthe surface of the layer. For example, at least a portion of theencapsulations can be positioned within domes extending upwardly fromthe layer. In certain embodiments, the encapsulations may comprisepockets formed within the layer. In certain embodiments, a first portionof the encapsulations may comprise a dome and a second portion of theencapsulations may comprise a pocket. In certain embodiments, theencapsulations may comprise a tube embedded within the layer. In certainembodiments, the tube may comprise the non-synthetic materials and/orsynthetic materials described herein, such as PLA. In at least oneembodiment, the tissue thickness compensator may comprise a bioabsorablefoam, such as ORC, comprising PLA tubes embedded therein, and the tubemay encapsulate a hydrogel, for example. In certain embodiments, theencapsulations may comprise discrete cells that are unconnected to eachother. In certain embodiments, one or more of the encapsulations can bein fluid communication with each other via one or more passageways,conduits, and/or channels, for example, extending through the layer.

The rate of release of a component from the encapsulation may becontrolled by the thickness of the tissue thickness compensator, thecomposition of tissue thickness compensator, the size of the component,the hydrophilicity of the component, and/or the physical and/or chemicalinteractions among the component, the composition of the tissuethickness compensator, and/or the surgical instrument, for example. Invarious embodiments, the layer can comprise one or more thin sections orweakened portions, such as partial perforations, for example, which canfacilitate the incision of the layer and the rupture of theencapsulations. In various embodiments, the partial perforations may notcompletely extend through a layer while, in certain embodiments,perforations may completely extend through the layer.

In various embodiments, an anvil may comprise a tissue thicknesscompensator comprising an encapsulated component comprising at least onemicrosphere particle. In certain embodiments, the tissue thicknesscompensator may comprise an encapsulation comprising a firstencapsulated component and a second encapsulated component. In certainembodiments, the tissue thickness compensator may comprise anencapsulation comprising a first microsphere particle and a secondmicrosphere particle.

In various embodiments, the tissue thickness compensator may be suitablefor use with a surgical instrument. As described above the tissuethickness compensator may be associated with the staple cartridge and/orthe anvil. The tissue thickness compensator may be configured into anyshape, size and/or dimension suitable to fit the staple cartridge and/oranvil. As described herein, the tissue thickness compensator may bereleasably attached to the staple cartridge and/or anvil. The tissuethickness compensator may be attached to the staple cartridge and/oranvil in any mechanical and/or chemical manner capable of retaining thetissue thickness compensator in contact with the staple cartridge and/oranvil prior to and during the stapling process. The tissue thicknesscompensator may be removed or released from the staple cartridge and/oranvil after the staple penetrates the tissue thickness compensator. Thetissue thickness compensator may be removed or released from the staplecartridge and/or anvil as the staple cartridge and/or anvil is movedaway from the tissue thickness compensator.

In various embodiments, referring now to FIG. 14, a staple cartridge,such as staple cartridge 10000, for example, can comprise a supportportion 10010 and a compressible tissue thickness compensator 10020.Referring now to FIGS. 16-18, the support portion 10010 can comprise adeck surface 10011 and a plurality of staple cavities 10012 definedwithin the support portion 10010. Each staple cavity 10012 can be sizedand configured to removably store a staple, such as a staple 10030, forexample, therein. The staple cartridge 10000 can further comprise aplurality of staple drivers 10040 which can each be configured tosupport one or more staples 10030 within the staple cavities 10012 whenthe staples 10030 and the staple drivers 10040 are in their unfiredpositions. In at least one such embodiment, referring primarily to FIGS.22 and 23, each staple driver 10040 can comprise one or more cradles, ortroughs, 10041, for example, which can be configured to support thestaples and limit relative movement between the staples 10030 and thestaple drivers 10040. In various embodiments, referring again to FIG.16, the staple cartridge 10000 can further comprise a staple-firing sled10050 which can be moved from a proximal end 10001 to a distal end 10002of the staple cartridge in order to sequentially lift the staple drivers10040 and the staples 10030 from their unfired positions toward an anvilpositioned opposite the staple cartridge 10000. In certain embodiments,referring primarily to FIGS. 16 and 18, each staple 10030 can comprise abase 10031 and one or more legs 10032 extending from the base 10031wherein each staple can be at least one of substantially U-shaped andsubstantially V-shaped, for example. In at least one embodiment, thestaples 10030 can be configured such that the tips of the staple legs10032 are recessed with respect to the deck surface 10011 of the supportportion 10010 when the staples 10030 are in their unfired positions. Inat least one embodiment, the staples 10030 can be configured such thatthe tips of the staple legs 10032 are flush with respect to the decksurface 10011 of the support portion 10010 when the staples 10030 are intheir unfired positions. In at least one embodiment, the staples 10030can be configured such that the tips of the staple legs 10032, or atleast some portion of the staple legs 10032, extend above the decksurface 10011 of the support portion 10010 when the staples 10030 are intheir unfired positions. In such embodiments, the staple legs 10032 canextend into and can be embedded within the tissue thickness compensator10020 when the staples 10030 are in their unfired positions. In at leastone such embodiment, the staple legs 10032 can extend above the decksurface 10011 by approximately 0.075″, for example. In variousembodiments, the staple legs 10032 can extend above the deck surface10011 by a distance between approximately 0.025″ and approximately0.125″, for example. In certain embodiments, further to the above, thetissue thickness compensator 10020 can comprise an uncompressedthickness between approximately 0.08″ and approximately 0.125″, forexample.

In use, further to the above and referring primarily to FIG. 31, ananvil, such as anvil, 10060, for example, can be moved into a closedposition opposite the staple cartridge 10000. As described in greaterdetail below, the anvil 10060 can position tissue against the tissuethickness compensator 10020 and, in various embodiments, compress thetissue thickness compensator 10020 against the deck surface 10011 of thesupport portion 10010, for example. Once the anvil 10060 has beensuitably positioned, the staples 10030 can be deployed, as alsoillustrated in FIG. 31. In various embodiments, as mentioned above, thestaple-firing sled 10050 can be moved from the proximal end 10001 of thestaple cartridge 10000 toward the distal end 10002, as illustrated inFIG. 32. As the sled 10050 is advanced, the sled 10050 can contact thestaple drivers 10040 and lift the staple drivers 10040 upwardly withinthe staple cavities 10012. In at least one embodiment, the sled 10050and the staple drivers 10040 can each comprise one or more ramps, orinclined surfaces, which can co-operate to move the staple drivers 10040upwardly from their unfired positions. In at least one such embodiment,referring to FIGS. 19-23, each staple driver 10040 can comprise at leastone inclined surface 10042 and the sled 10050 can comprise one or moreinclined surfaces 10052 which can be configured such that the inclinedsurfaces 10052 can slide under the inclined surface 10042 as the sled10050 is advanced distally within the staple cartridge. As the stapledrivers 10040 are lifted upwardly within their respective staplecavities 10012, the staple drivers 10040 can lift the staples 10030upwardly such that the staples 10030 can emerge from their staplecavities 10012 through openings in the staple deck 10011. During anexemplary firing sequence, referring primarily to FIGS. 25-27, the sled10050 can first contact staple 10030 a and begin to lift the staple10030 a upwardly. As the sled 10050 is advanced further distally, thesled 10050 can begin to lift staples 10030 b, 10030 c, 10030 d, 10030 e,and 10030 f, and any other subsequent staples, in a sequential order. Asillustrated in FIG. 27, the sled 10050 can drive the staples 10030upwardly such that the legs 10032 of the staples contact the opposinganvil, are deformed to a desired shape, and ejected therefrom thesupport portion 10010. In various circumstances, the sled 10030 can moveseveral staples upwardly at the same time as part of a firing sequence.With regard to the firing sequence illustrated in FIG. 27, the staples10030 a and 10030 b have been moved into their fully fired positions andejected from the support portion 10010, the staples 10030 c and 10030 dare in the process of being fired and are at least partially containedwithin the support portion 10010, and the staples 10030 e and 10030 fare still in their unfired positions.

As discussed above, and referring to FIG. 33, the staple legs 10032 ofthe staples 10030 can extend above the deck surface 10011 of the supportportion 10010 when the staples 10030 are in their unfired positions.With further regard to this firing sequence illustrated in FIG. 27, thestaples 10030 e and 10030 f are illustrated in their unfired positionand their staple legs 10032 extend above the deck surface 10011 and intothe tissue thickness compensator 10020. In various embodiments, the tipsof the staple legs 10032, or any other portion of the staple legs 10032,may not protrude through a top tissue-contacting surface 10021 of thetissue thickness compensator 10020 when the staples 10030 are in theirunfired positions. As the staples 10030 are moved from their unfiredpositions to their fired positions, as illustrated in FIG. 27, the tipsof the staple legs can protrude through the tissue-contacting surface10032. In various embodiments, the tips of the staple legs 10032 cancomprise sharp tips which can incise and penetrate the tissue thicknesscompensator 10020. In certain embodiments, the tissue thicknesscompensator 10020 can comprise a plurality of apertures which can beconfigured to receive the staple legs 10032 and allow the staple legs10032 to slide relative to the tissue thickness compensator 10020. Incertain embodiments, the support portion 10010 can further comprise aplurality of guides 10013 extending from the deck surface 10011. Theguides 10013 can be positioned adjacent to the staple cavity openings inthe deck surface 10011 such that the staple legs 10032 can be at leastpartially supported by the guides 10013. In certain embodiments, a guide10013 can be positioned at a proximal end and/or a distal end of astaple cavity opening. In various embodiments, a first guide 10013 canbe positioned at a first end of each staple cavity opening and a secondguide 10013 can be positioned at a second end of each staple cavityopening such that each first guide 10013 can support a first staple leg10032 of a staple 10030 and each second guide 10013 can support a secondstaple leg 10032 of the staple. In at least one embodiment, referring toFIG. 33, each guide 10013 can comprise a groove or slot, such as groove10016, for example, within which a staple leg 10032 can be slidablyreceived. In various embodiments, each guide 10013 can comprise a cleat,protrusion, and/or spike that can extend from the deck surface 10011 andcan extend into the tissue thickness compensator 10020. In at least oneembodiment, as discussed in greater detail below, the cleats,protrusions, and/or spikes can reduce relative movement between thetissue thickness compensator 10020 and the support portion 10010. Incertain embodiments, the tips of the staple legs 10032 may be positionedwithin the guides 10013 and may not extend above the top surfaces of theguides 10013 when the staples 10030 are in their unfired position. In atleast such embodiment, the guides 10013 can define a guide height andthe staples 10030 may not extend above this guide height when they arein their unfired position.

In various embodiments, a tissue thickness compensator, such as tissuethickness compensator 10020, for example, can be comprised of a singlesheet of material. In at least one embodiment, a tissue thicknesscompensator can comprise a continuous sheet of material which can coverthe entire top deck surface 10011 of the support portion 10010 or,alternatively, cover less than the entire deck surface 10011. In certainembodiments, the sheet of material can cover the staple cavity openingsin the support portion 10010 while, in other embodiments, the sheet ofmaterial can comprise openings which can be aligned, or at leastpartially aligned, with the staple cavity openings. In variousembodiments, a tissue thickness compensator can be comprised of multiplelayers of material. In some embodiments, referring now to FIG. 15, atissue thickness compensator can comprise a compressible core and a wrapsurrounding the compressible core. In certain embodiments, a wrap 10022can be configured to releasably hold the compressible core to thesupport portion 10010. In at least one such embodiment, the supportportion 10010 can comprise one or more projections, such as projections10014 (FIG. 18), for example, extending therefrom which can be receivedwithin one or more apertures and/or slots, such as apertures 10024, forexample, defined in the wrap 10022. The projections 10014 and theapertures 10024 can be configured such that the projections 10014 canretain the wrap 10022 to the support portion 10010. In at least oneembodiment, the ends of the projections 10014 can be deformed, such asby a heat-stake process, for example, in order to enlarge the ends ofthe projections 10014 and, as a result, limit the relative movementbetween the wrap 10022 and the support portion 10010. In at least oneembodiment, the wrap 10022 can comprise one or more perforations 10025which can facilitate the release of the wrap 10022 from the supportportion 10010, as illustrated in FIG. 15. Referring now to FIG. 24, atissue thickness compensator can comprise a wrap 10222 including aplurality of apertures 10223, wherein the apertures 10223 can bealigned, or at least partially aligned, with the staple cavity openingsin the support portion 10010. In certain embodiments, the core of thetissue thickness compensator can also comprise apertures which arealigned, or at least partially aligned, with the apertures 10223 in thewrap 10222. In other embodiments, the core of the tissue thicknesscompensator can comprise a continuous body and can extend underneath theapertures 10223 such that the continuous body covers the staple cavityopenings in the deck surface 10011.

In various embodiments, as described above, a tissue thicknesscompensator can comprise a wrap for releasably holding a compressiblecore to the support portion 10010. In at least one such embodiment,referring to FIG. 16, a staple cartridge can further comprise retainerclips 10026 which can be configured to inhibit the wrap, and thecompressible core, from prematurely detaching from the support portion10010. In various embodiments, each retainer clip 10026 can compriseapertures 10028 which can be configured to receive the projections 10014extending from the support portion 10010 such that the retainer clips10026 can be retained to the support portion 10010. In certainembodiments, the retainer clips 10026 can each comprise at least one panportion 10027 which can extend underneath the support portion 10010 andcan support and retain the staple drivers 10040 within the supportportion 10010. In certain embodiments, as described above, a tissuethickness compensator can be removably attached to the support portion10010 by the staples 10030. More particularly, as also described above,the legs of the staples 10030 can extend into the tissue thicknesscompensator 10020 when the staples 10030 are in their unfired positionand, as a result, releasably hold the tissue thickness compensator 10020to the support portion 10010. In at least one embodiment, the legs ofthe staples 10030 can be in contact with the sidewalls of theirrespective staple cavities 10012 wherein, owing to friction between thestaple legs 10032 and the sidewalls, the staples 10030 and the tissuethickness compensator 10020 can be retained in position until thestaples 10030 are deployed from the staple cartridge 10000. When thestaples 10030 are deployed, the tissue thickness compensator 10020 canbe captured within the staples 10030 and held against the stapled tissueT. When the anvil is thereafter moved into an open position to releasethe tissue T, the support portion 10010 can be moved away from thetissue thickness compensator 10020 which has been fastened to thetissue. In certain embodiments, an adhesive can be utilized to removablyhold the tissue thickness compensator 10020 to the support portion10010. In at least one embodiment, a two-part adhesive can be utilizedwherein, in at least one embodiment, a first part of the adhesive can beplaced on the deck surface 10011 and a second part of the adhesive canbe placed on the tissue thickness compensator 10020 such that, when thetissue thickness compensator 10020 is placed against the deck surface10011, the first part can contact the second part to active the adhesiveand detachably bond the tissue thickness compensator 10020 to thesupport portion 10010. In various embodiments, any other suitable meanscould be used to detachably retain the tissue thickness compensator tothe support portion of a staple cartridge.

In various embodiments, further to the above, the sled 10050 can beadvanced from the proximal end 10001 to the distal end 10002 to fullydeploy all of the staples 10030 contained within the staple cartridge10000. In at least one embodiment, referring now to FIGS. 56-60, thesled 10050 can be advanced distally within a longitudinal cavity 10016within the support portion 10010 by a firing member, or knife bar, 10052of a surgical stapler. In use, the staple cartridge 10000 can beinserted into a staple cartridge channel in a jaw of the surgicalstapler, such as staple cartridge channel 10070, for example, and thefiring member 10052 can be advanced into contact with the sled 10050, asillustrated in FIG. 56. As the sled 10050 is advanced distally by thefiring member 10052, the sled 10050 can contact the proximal-most stapledriver, or drivers, 10040 and fire, or eject, the staples 10030 from thecartridge body 10010, as described above. As illustrated in FIG. 56, thefiring member 10052 can further comprise a cutting edge 10053 which canbe advanced distally through a knife slot in the support portion 10010as the staples 10030 are being fired. In various embodiments, acorresponding knife slot can extend through the anvil positionedopposite the staple cartridge 10000 such that, in at least oneembodiment, the cutting edge 10053 can extend between the anvil and thesupport portion 10010 and incise the tissue and the tissue thicknesscompensator positioned therebetween. In various circumstances, the sled10050 can be advanced distally by the firing member 10052 until the sled10050 reaches the distal end 10002 of the staple cartridge 10000, asillustrated in FIG. 58. At such point, the firing member 10052 can beretracted proximally. In some embodiments, the sled 10050 can beretracted proximally with the firing member 10052 but, in variousembodiments, referring now to FIG. 59, the sled 10050 can be left behindin the distal end 10002 of the staple cartridge 10000 when the firingmember 10052 is retracted. Once the firing member 10052 has beensufficiently retracted, the anvil can be re-opened, the tissue thicknesscompensator 10020 can be detached from the support portion 10010, andthe remaining non-implanted portion of the expended staple cartridge10000, including the support portion 10010, can be removed from thestaple cartridge channel 10070.

After the expended staple cartridge 10000 has been removed from thestaple cartridge channel, further to the above, a new staple cartridge10000, or any other suitable staple cartridge, can be inserted into thestaple cartridge channel 10070. In various embodiments, further to theabove, the staple cartridge channel 10070, the firing member 10052,and/or the staple cartridge 10000 can comprise co-operating featureswhich can prevent the firing member 10052 from being advanced distally asecond, or subsequent, time without a new, or unfired, staple cartridge10000 positioned in the staple cartridge channel 10070. Moreparticularly, referring again to FIG. 56, as the firing member 10052 isadvanced into contact with the sled 10050 and, when the sled 10050 is inits proximal unfired position, a support nose 10055 of the firing member10052 can be positioned on and/or over a support ledge 10056 on the sled10050 such that the firing member 10052 is held in a sufficient upwardposition to prevent a lock, or beam, 10054 extending from the firingmember 10052 from dropping into a lock recess defined within the staplecartridge channel. As the lock 10054 will not drop into the lock recess,in such circumstances, the lock 10054 may not abut a distal sidewall10057 of the lock recess as the firing member 10052 is advanced. As thefiring member 10052 pushes the sled 10050 distally, the firing member10052 can be supported in its upward firing position owing to thesupport nose 10055 resting on the support ledge 10056. When the firingmember 10052 is retracted relative to the sled 10050, as discussed aboveand illustrated in FIG. 59, the firing member 10052 can drop downwardlyfrom its upward position as the support nose 10055 is no longer restingon the support ledge 10056 of the sled 10050. In at least one suchembodiment, the surgical staple can comprise a spring 10058, and/or anyother suitable biasing element, which can be configured to bias thefiring member 10052 into its downward position. Once the firing member10052 has been completely retracted, as illustrated in FIG. 60, thefiring member 10052 cannot be advanced distally through the spent staplecartridge 10000 once again. More particularly, the firing member 10052can't be held in its upper position by the sled 10050 as the sled 10050,at this point in the operating sequence, has been left behind at thedistal end 10002 of the staple cartridge 10000. Thus, as mentionedabove, in the event that the firing member 10052 is advanced once againwithout replacing the staple cartridge, the lock beam 10054 will contactthe sidewall 10057 of the lock recess which will prevent the firingmember 10052 from being advanced distally into the staple cartridge10000 once again. Stated another way, once the spent staple cartridge10000 has been replaced with a new staple cartridge, the new staplecartridge will have a proximally-positioned sled 10050 which can holdthe firing member 10052 in its upper position and allow the firingmember 10052 to be advanced distally once again.

As described above, the sled 10050 can be configured to move the stapledrivers 10040 between a first, unfired position and a second, firedposition in order to eject staples 10030 from the support portion 10010.In various embodiments, the staple drivers 10040 can be contained withinthe staple cavities 10012 after the staples 10030 have been ejected fromthe support portion 10010. In certain embodiments, the support portion10010 can comprise one or more retention features which can beconfigured to block the staple drivers 10040 from being ejected from, orfalling out of, the staple cavities 10012. In various other embodiments,the sled 10050 can be configured to eject the staple drivers 10040 fromthe support portion 10010 with the staples 10030. In at least one suchembodiment, the staple drivers 10040 can be comprised of a bioabsorbableand/or biocompatible material, such as Ultem, for example. In certainembodiments, the staple drivers can be attached to the staples 10030. Inat least one such embodiment, a staple driver can be molded over and/oraround the base of each staple 10030 such that the driver is integrallyformed with the staple. U.S. patent application Ser. No. 11/541,123,entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FORSECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME,filed on Sep. 29, 2006, is hereby incorporated by reference in itsentirety.

As described above, a surgical stapling instrument can comprise a staplecartridge channel configured to receive a staple cartridge, an anvilrotatably coupled to the staple cartridge channel, and a firing membercomprising a knife edge which is movable relative to the anvil and thestaple cartridge channel. In use, a staple cartridge can be positionedwithin the staple cartridge channel and, after the staple cartridge hasbeen at least partially expended, the staple cartridge can be removedfrom the staple cartridge channel and replaced with a new staplecartridge. In some such embodiments, the staple cartridge channel, theanvil, and/or the firing member of the surgical stapling instrument maybe re-used with the replacement staple cartridge. In certain otherembodiments, a staple cartridge may comprise a part of a disposableloading unit assembly which can include a staple cartridge channel, ananvil, and/or a firing member, for example, which can be replaced alongwith the staple cartridge as part of replacing the disposable loadingunit assembly. Certain disposable loading unit assemblies are disclosedin U.S. patent application Ser. No. 12/031,817, entitled END EFFECTORCOUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT,which was filed on Feb. 15, 2008, the entire disclosure of which isincorporated by reference herein.

In various embodiments, the tissue thickness compensator may comprise anextrudable, a castable, and/or moldable composition comprising at leastone of the synthetic and/or non-synthetic materials described herein. Invarious embodiments, the tissue thickness compensator may comprise afilm or sheet comprising two or more layers. The tissue thicknesscompensator may be obtained using conventional methods, such as, forexample, mixing, blending, compounding, spraying, wicking, solventevaporating, dipping, brushing, vapor deposition, extruding,calendaring, casting, molding and the like. In extrusion, an opening maybe in the form of a die comprising at least one opening to impart ashape to the emerging extrudate. In calendering, an opening may comprisea nip between two rolls. Conventional molding methods may include, butare not limited to, blow molding, injection molding, foam injection,compression molding, thermoforming, extrusion, foam extrusion, filmblowing, calendaring, spinning, solvent welding, coating methods, suchas dip coating and spin coating, solution casting and film casting,plastisol processing (including knife coating, roller coating andcasting), and combinations thereof. In injection molding, an opening maycomprise a nozzle and/or channels/runners and/or mold cavities andfeatures. In compression molding, the composition may be positioned in amold cavity, heated to a suitable temperature, and shaped by exposure tocompression under relatively high pressure. In casting, the compositionmay comprise a liquid or slurry that may be poured or otherwise providedinto, onto and/or around a mold or object to replicate features of themold or object. After casting, the composition may be dried, cooled,and/or cured to form a solid.

In various embodiments, a method of manufacturing a tissue thicknesscompensator comprising at least one medicament stored and/or absorbedtherein may generally comprise providing a tissue thickness compensatorand contacting the tissue thickness compensator and the medicament toretain the medicament in the tissue thickness compensator. In at leastone embodiment, a method of manufacturing a tissue thickness compensatorcomprising an antibacterial material may comprise providing a hydrogel,drying the hydrogel, swelling the hydrogel in an aqueous solution ofsilver nitrate, contacting the hydrogel and a solution of sodiumchloride to form the tissue thickness compensator having antibacterialproperties. The tissue thickness compensator may comprise silverdispersed therein.

In various embodiments, referring now to FIG. 71, a tissue thicknesscompensator 21020 can comprise a compensator body 21022 and a pluralityof capsules, or tubes, 21024 positioned therein. In at least oneembodiment, each of the tubes 21024 can include a cavity 21026 definedtherein which can include one or more medicaments therein. As describedin greater detail below, the tissue thickness compensator 21020 can bemanufactured by placing the tubes 21024 in a mold, for example, andforming the compensator body 21022 around the tubes 21024. In certainembodiments, the one or medicaments can be placed in the tubes 21024before the tubes 21024 are placed in the mold such that, after thecompensator body 21022 has solidified, lyophilized, and/or cured, forexample, the tubes 21024 can be encapsulated in the compensator body21022. In other embodiments, referring now to FIG. 72, a tissuethickness compensator 21120 can comprise a plurality of capsules, ortubes, 21124 positioned within a compensator body 21122 wherein one ormore medicaments can be loaded into the tubes 21124 after thecompensator body 21122 has been formed around the tubes 21124. In atleast one such embodiment, the tissue thickness compensator 21120 cancomprise a port 21123 which can be in fluid communication with the tubes21124 and can be configured to permit the one or medicaments to beinjected into the tubes 21124 utilizing a syringe 21125, for example. Insome circumstances, a surgeon, or other clinician, can load the one ormore medicaments into the tubes 21124 just before the tissue thicknesscompensator 21120 is inserted into the patient. Such embodiments may beespecially useful when the tissue thickness compensator 21120 may beexpected to, or required to, have a long storage duration, orshelf-life.

In various embodiments, referring now to FIG. 73, the compensator body21022 of the tissue thickness compensator 21020 can be comprised of abioabsorbable material, for example. In at least one embodiment, thecompensator body 21022 can be comprised of any suitable material, suchas PGA and/or PCL, for example. In certain embodiments, the tubes 21024can be comprised of any suitable of a bioabsorbable material, forexample. In at least one embodiment, the tubes 21024 can be comprised ofany suitable material, such as hyaluronic acid, gelatin, PDS, and/oroxidized regenerated cellulose (ORC), for example. In at least oneembodiment, the one or medicaments 21025 contained within the cavity21026 can comprise a fluid, such as, doxycycline, for example. In atleast one such embodiment, each of the tubes 21024 can be sealed suchthat the medicaments 21025 can be stored within the tubes 21024 until atleast a portion of the tubes 21024 have been dissolved and/orbioabsorbed, for example. In use, referring now to FIG. 74, the tubes21024 can be exposed to a bodily fluid, such as blood, for example,which can come into contact with and dissolve the tubes 21024. In atleast one embodiment, referring to FIG. 75, the bodily fluid can beexpressed from tissue T when the tissue T and the tissue thicknesscompensator 21020 are compressed by an anvil 21060 and/or a plurality ofstaples 21030, for example. In various embodiments, a bioabsorbable wrapcan be utilized to enclose, or at least partially enclose, thecompensator body 21022. In at least one such embodiment, the wrap can becomprised of hyaluronic acid and/or ORC, for example.

In various embodiments, referring now to FIG. 77, a capsule, or tube,21224 can comprise a plurality of layers 21224 a-21224 d, for example.In at least one embodiment, each tube 21224 can comprise an outer, orfirst, layer 21224 a, a second layer 21224 b, a third layer 21224 c, andan inner layer 21224 d, for example. In various embodiments, the outerlayer 21224 a can be comprised of a haemostatic material, such asthrombin, for example. The second layer 21224 b can be comprised of ananti-microbial and/or anti-biotic material, such as doxycycline and/orgentamicin, for example. The third layer 21224 c can be comprised of ananti-inflammatory material, such as diclofenac and/or NSAIDSs, forexample. The inner layer 21224 d can be comprised of a healinginfluencing material, such as a powdered collageno synthetic material,for example. Referring again to FIG. 77, the tube 21224 can bestructured and arranged such that the outer layer 21224 a is dissolved,or at least substantially dissolved, before the second layer 21224 b isdissolved, or at least partially dissolved. In various embodiments,referring to FIG. 76, the outer layer 21224 a can begin dissolve as soonas it is exposed to a bodily fluid. This moment in time is indicated astime t0. In certain embodiments, the outer layer 21224 a can becompletely dissolved over the course of minutes, hours, and/or dayswherein the material comprising the outer layer 21224 a can reach amaximum efficacy or concentration at a moment in time indicated as timet1. At some later moment in time, the outer layer 21224 a can becompletely, or at least substantially, dissolved by a moment in timeindicated by time t2.

As the outer layer 21224 a is being dissolved, the bodily fluid canreach the second layer 21224 b and begin to at least partially dissolvethe second layer 21224 b. Similar to the above, the second layer 21224 bcan be completely dissolved over the course of minutes, hours, and/ordays wherein the material comprising the second layer 21224 b can reacha maximum efficacy or concentration at a moment in time indicated astime t3. In various circumstances, a bodily fluid can pass through theouter layer 21224 a to reach the second layer 21224 b such that theouter layer 21224 a and the second layer 21224 b can begin to dissolveat the same, or at least substantially the same, time. In any event, thereader will note that the time t1 in which the material comprising theouter layer 21224 a reaches its maximum efficacy or concentration canoccur before time t3. At some later moment in time, the second layer21224 b can be completely, or at least substantially, dissolved by amoment in time indicated by time t5. As the reader will also note, thetime t5 can occur after time t2. As the second layer 21224 b is beingdissolved, the bodily fluid can reach the third layer 21224 c and beginto at least partially dissolve the third layer 21224 c. Similar to theabove, the third layer 21224 c can be completely dissolved over thecourse of minutes, hours, and/or days wherein the material comprisingthe third layer 21224 c can reach a maximum efficacy or concentration ata moment in time indicated as time t6. In various circumstances, abodily fluid can pass through the outer layer 21224 a and the secondlayer 21224 b to reach the third layer 21224 c such that the outer layer21224 a, the second layer 21224 b, and/or the third layer 21224 c canbegin to dissolve at the same, or at least substantially the same, time.In any event, the reader will note that the time t3 in which thematerial comprising the second layer 21224 b reaches its maximumefficacy or concentration can occur before time t6. At some later momentin time, the third layer 21224 c can be completely, or at leastsubstantially, dissolved by a moment in time indicated by time t8. Asthe reader will also note, the time t8 can occur after time t5.

As the third layer 21224 c is being dissolved, the bodily fluid canreach the fourth layer 21224 d and begin to at least partially dissolvethe fourth layer 21224 d at a moment in time indicated by time t4.Similar to the above, the fourth layer 21224 b can be completelydissolved over the course of minutes, hours, and/or days wherein thematerial comprising the fourth layer 21224 d can reach a maximumefficacy or concentration at a moment in time indicated as time t7. Invarious circumstances, a bodily fluid can pass through the outer layer21224 a, the second layer 21224 b, and the third layer 21224 c to reachthe fourth layer 21224 d such that the outer layer 21224 a, the secondlayer 21224 b, the third layer 21224 c, and/or the fourth layer 21224 dcan begin to dissolve at the same, or at least substantially the same,time. In any event, the reader will note that the time t6 in which thematerial comprising the third layer 21224 c reaches its maximum efficacyor concentration can occur before time t7. At some later moment in time,the fourth layer 21224 d can be completely, or at least substantially,dissolved by a moment in time indicated by time t9. As the reader willalso note, the time t9 can occur after time t8. In various embodiments,as a result of the above, a staged release of medicaments can occur.

In various embodiments, referring now to FIGS. 81 and 83, a staplecartridge 21300 can comprise a cartridge body 21310 including aplurality of staple cavities 21312 and a plurality of staples 21330positioned therein. The staple cartridge 21300 can further comprise atissue thickness compensator 21320 which can include a compensator body21322 positionable against the cartridge body 21310 and, in addition, aplurality of discrete capsules 21324 positioned within the compensatorbody 21322. In at least one embodiment, the capsules 21324 can bevertically oriented and, when the staples 21330 are in their unfiredconfiguration, as illustrated in FIG. 83, each capsule 21324 can bepositioned between the staple legs 21322 of a staple 21330. In at leastone such embodiment, the staple legs 21322 may at least partially extendinto the tissue thickness compensator 21320 when the staples 21330 arein their unfired position without rupturing the capsules 21324. When thestaples 21330 are moved from their unfired position to their firedposition, referring now to FIG. 84, the staples 21330 can rupture thecapsules 21324 and thereby release the at least one medicament storedtherein. More particularly, in at least one embodiment, the staples21330 can be deformed by the forming pockets 21062 defined in the anvil21060 when the staples 21330 are lifted upwardly such that the staplelegs 21332 can be curled, or deformed, downwardly and inwardly towardthe capsules 21324 positioned therebetween. In at least one embodiment,the staples 21330 can be lifted upwardly by a firing system comprisingdrivers 21340 and sled 21345 wherein the sled 21345 can be configured tolongitudinally traverse the staple cartridge 21000 and sequentially liftand fire the staple drivers 21340 and the staples 21330 positionedthereon. In any event, the staple legs 21332 can pierce and/or crush thecapsules 21324 such that the internal cavities 21326 defined in thecapsules 21324 can be breached and the one or more medicaments containedin the internal cavities 21326 can escape therefrom. In variousembodiments, the one or more medicaments can include one or more powdersand/or fluids contained therein, for example. In various embodiments,the staple cartridge 21300 can further comprise a cutting member 21380which can be advanced distally with the sled 21345 in order to transectthe tissue T positioned between the staple cartridge 21300 and the anvil21060, for example. In at least one embodiment, the cutting member 21380can be configured to pass through a knife slot 21314 defined in thecartridge body 21310 wherein, in at least one such embodiment, one ormore capsules, such as capsules 21324, for example, can be positionedwithin and/or above the knife slot 21314 such that the cutting member21380 can transect such capsules 21324. In any event, in variousembodiments, the tissue thickness compensator 21320 can further comprisea layer 21321 positioned on the top, and/or bottom, of the cartridgebody 21322 which, in at least one embodiment, can be comprised ofhyaluronic acid, for example, and can stabilize the cartridge body 21322and/or the staples 21330. In at least one such embodiment, the cuttingmember 21380 can be configured to transect the layer 21321 when thecutting member 21380 is advanced through the staple cartridge 21300 asdescribed above.

In various embodiments, referring now to FIG. 85, a tissue thicknesscompensator 21420 can comprise a compensator body 21422 and a pluralityof capsules 21444 positioned therein. In at least one embodiment,similar to the above, each capsule 21444 can comprise a sealed cavity21446 which can be configured to releasably store one or medicamentstherein. In certain embodiments, each of the capsules 21444 can comprisea conical and/or tapered end 21447, for example. In at least one suchembodiment, the tapered ends 21447 can be utilized to hold the capsules21444 in position while the cartridge body 21422 is being formed aroundit. In various embodiments, a mold can include a plurality of aperturesand/or indentations which can be configured to receive and secure thetapered ends 21447 such that, when the compensator material is pouredaround the capsules 21444, the mold can hold the capsules 21444 inposition. In certain embodiments, further to the above, the capsules21444 can be positioned and arranged such that they may not be rupturedor burst until staples are fired into and/or through the tissuethickness compensator 21420 during use, for example.

In certain other embodiments, referring now to FIG. 86, a tissuethickness compensator 21520 can comprise a plurality of capsules 21524positioned within a compensator body 21522. In at least one embodiment,the capsules 21524 can each comprise one or more apertures 21528 definedin the outer wall thereof wherein the apertures 21528 can be configuredto permit one or medicaments 21525 to escape from the cavities 21526defined in the capsules 21524. In various embodiments, the apertures21528 can be sized and configured to control the rate in which themedicaments 21525 escape from the cavities 21526. For instance, largerapertures 21528 can permit a faster release of the medicaments 21525while smaller apertures 21528 can permit a slower release of themedicaments 21525, for example. In at least one embodiment, the outerwall of each capsule 21524 can be comprised of a tube having ends 21527which are closed and/or sealed. In various embodiments, the outer wallsof the capsules 21524 can be comprised of one or more bioabsorbablepolymers, for example, and, in at least one embodiment, the ends 21527can be closed and/or sealed utilizing a heat-staking process, athermal-welding process, and/or a laser welding process, for example. Incertain embodiments, the outer walls, or shells, of the capsules 21524can be manufactured utilizing an injection molding process wherein,after the shells have been formed, one or medicaments can be positionedinto the shells through one or more open ends thereof. Thereafter, in atleast one embodiment, the open end, or ends, in the shell can be cappedutilizing a polymer solution, for example. In embodiments in which thewalls of the capsules 21524 are comprised of a bioabsorbable material,the apertures 21528 defined therein can grow over time. In at least onesuch embodiment, the rate in which the medicaments 21525 are releasedfrom the cavities 21526 can increase over time.

In various embodiments, the compensator body 21522 can be comprised ofgelatin, for example, and can be manufactured into a foam materialutilizing a lypholization process, for example. In at least oneembodiment, the capsules 21524 can be inserted into the compensator body21522 wherein, in at least one such embodiment, the compensator body21522 can be formed with apertures configured to receive the capsules21524. In at least one such embodiment, a layer, or film, could then beplaced over the compensator body 21522 to cap or enclose the capsules21524 therein. In certain other embodiments, the capsules 21524 can bepositioned within a mold and a compensator material can be formed atleast partially around the capsules 21524 to form the compensator body21522. In any event, the compensator body 21552 can comprise one or morekeying, or indexing, features which can be configured to align andorient the tissue thickness compensator 21520 with a cartridge body ofstaple cartridge such that the capsules 21524 are positioned in adesired position.

In various embodiments, referring now to FIG. 87, a surgical staplingsystem can include a staple cartridge 21600 and an anvil 21060, whereinthe staple cartridge 21600 and the anvil 21060 can be positioned onopposite sides of tissue T. Similar to other staple cartridges disclosedherein, the staple cartridge 21600 can comprise a cartridge body 21310including a plurality of staple cavities 21312 and a plurality ofstaples 21330 positioned therein. In use, referring to FIG. 91, thestaples 21330 can be lifted upwardly by drivers 21340 from an unfiredposition to a fired position such that they are deformed against theanvil 21060 or, more particularly, deformed within the forming pockets21062. As the staples 21330 are being fired, the staples 21330 canpierce the tissue T and a tissue thickness compensator 21620 attached tothe anvil 21060 before the staples 21330 are deformed between theirunfired configuration (FIG. 88) and their fired configuration (FIG. 89).In various embodiments, the staples 21330 can be comprised of anysuitable material such as stainless steel and/or titanium, for example,and can be configured to apply a compression or clamping force againstthe tissue thickness compensator 21620 and the tissue T. In at least oneembodiment, as illustrated in FIG. 87, the staples 21330 can be arrangedin a plurality of rows wherein one staple 21330 can be positioned ineach staple cavity 21312. In various embodiments, the staple cartridge21300 can further comprise piercing members 21635 (FIG. 90) which can beconfigured to engage and pierce the tissue T, the tissue thicknesscompensator 21620, and/or one or medicament capsules positioned withinthe tissue thickness compensator 21620, for example. In at least onesuch embodiment, the piercing members 21635 can be positioned within thestaple cavities 21312 wherein the piercing members 21635 can be fired,or ejected, from the staple cavities 21312 by the drivers 21340. Incertain embodiments, further to the above, some staple cavities 21312 ofthe staple cartridge 21600 can include staples 21330 positioned thereinwhile other staple cavities 21312 can include piercing members 21635positioned therein. In various embodiments, the staple cartridge 21600can include some rows of staple cavities 21312 having only staples 21330positioned therein, some rows having only piercing members 21635positioned therein, and/or some rows having both staples 21330 andpiercing members 21635 positioned therein. In at least the illustratedembodiment, referring to FIG. 91, the inner four rows of staple cavities21312 may only comprise staples 21330 therein while the outer rows ofstaple cavities 21312 may comprise both staples 21330 and piercingmembers 21635 therein. In various embodiments, the staples 21330 and thepiercing members 21635 within the outer rows of staple cavities 21312may be arranged in an alternating arrangement, for example. Referringnow to FIG. 92, in at least one embodiment, the staples 21330 and thepiercing members 21635 may be arranged in a pattern which comprises twostaples 21330, followed by a piercing member 21635, followed by two morestaples 21330, followed by a piercing member 21635, and so forth, forexample.

In various embodiments, referring primarily to FIG. 90, each piercingmember 21635 can comprise a base 21638 and legs 21637 extending upwardlyfrom opposite sides of the base 21638. Referring now to FIG. 91, thedrivers 21340 can each comprise a trough 21348 which can be configuredto receive and support the base 21638 of a piercing member 21635. Whenthe drivers 21340 are pushed upwardly by the sled 21345, referring nowto FIG. 92, the sled 21345 can sequentially fire the staples 21330 andthe piercing members 21635. In various embodiments, referring now toFIG. 91, the staples 21330 may be deformed against the anvil 21060 whilethe piercing members 21635 may not touch the anvil 21060. In at leastone embodiment, referring primarily to FIG. 90, one or both of the legs21636 of each piercing member 21635 can include a sharp tip 21639 whichcan be configured to pierce the tissue T and/or the tissue thicknesscompensator 21620 and at least one barb 21637 which can be configured toretain the legs 21636 in the tissue T and/or the tissue thicknesscompensator 21620, for example. In some embodiments, a tissue thicknesscompensator may not be used at all. In certain embodiments, the legs21636 of the piercing members 21635 may not be long enough to pass allthe way through the tissue T, let alone touch the anvil 21060. Incertain other embodiments, the legs 21636 may be long enough such thatthey can contact the anvil 21060 and can be deformed into a differentconfiguration.

In various embodiments, the piercing members 21635 can be comprised of amaterial that is different than the material comprising the staples21330. In at least one embodiment, the piercing members 21635 can becomprised of at least one bioabsorbable polymer, such as PGA, forexample. In certain embodiments, the piercing members 21635 can eachcomprise at least one medicament, such as an anti-bacterial agent, ananti-inflammatory agent, pain medication, and/or a MMP inhibitor, forexample. As the piercing members 21635 can be located within the staplelines, for example, the piercing members 21635 can supply one or moremedicaments to the tissue T within and/or adjacent to the staple line asthe piercing members 21635 are being dissolved and/or bioabsorbed. Invarious embodiments, the piercing members 21635 can be coated with oneor more medicaments. In some embodiments, the piercing members 21635 cancomprise one or more medicaments embedded within a structural substratecomprising the piercing members 21635. In at least one embodiment, somepiercing members 21635 can be comprised of a first structural substrateand/or a first medicament while other piercing members 21635 can becomprised of a second, or different, structural substrate and/or asecond, or different, medicament, for example. In various embodiments,the piercing members 21635 can be manufactured utilizing an injectionmolding process, for example.

In various embodiments, referring now to FIGS. 93 and 94, a staplecartridge 21700 can include a cartridge body 21710 and a tissuethickness compensator 21720 positioned on or adjacent to a deck surface21711 of the cartridge body 21710. In at least one embodiment, similarto the above, the cartridge body 21710 can comprise a plurality ofstaples cavities 21312 and a plurality of staples positioned therein.The cartridge body 21710 can also include a slot 21714 which can beconfigured to receive a cutting member, such as cutting member 21380(FIG. 95), for example, therein. In use, as illustrated in FIG. 95, thecutting member 21380 can be configured to transect the tissue Tpositioned between the anvil 21060 and the staple cartridge 21700. Invarious embodiments, referring again to FIGS. 93 and 94, the tissuethickness compensator 21720 can comprise a compensator body 21722 and aplurality of medicament packets, or capsules, 21724 positioned withinthe compensator body 21722. In at least one embodiment, the capsules21724 can be positioned and arranged in the compensator body 21722 suchthat the capsules 21724 overlie the slot 21714 defined in the cartridgebody 21710. In use, referring primarily to FIG. 96, the cutting member21380 can be configured to incise the capsules 21724 as the cuttingmember 21380 is advanced through the staple cartridge 21700. In at leastone such embodiment, the capsules 21724 can be sealed prior to beingincised by the cutting member 21380 and, after the capsules 21724 havebeen incised, the one or more medicaments contained therein can bereleased. Owing to the position of the capsules 21724 over the slot21714, in various embodiments, the one or more medicaments can bereleased onto the portion of the tissue T which has been transected bythe cutting member 21380. In at least one embodiment, the one or moremedicaments contained within the capsules 21724 can comprise a biologicagent in the form of a powder, for example. In various embodiments, theone or more medicaments in the capsules 21724 can comprise oxidizedregenerated cellulose, alginate, and/or calcium, for example.

In various embodiments, referring again to FIGS. 93 and 94, the capsules21724 can comprise the same medicaments therein. In various otherembodiments, one or more of the capsules 21724 can comprise one or moredifferent medicaments therein. In at least one embodiment, a firstplurality of capsules 21724 can comprise a first medicament therein anda second plurality of capsules 21724 can comprise a second medicamenttherein. In at least one such embodiment, the capsules 21724 can bearranged in an alternating arrangement along the longitudinal path ofthe cutting member 21380, for example, such that a capsule 21724including the first medicament can be followed by a capsule 21724including the second medicament which can be followed by a capsule 21724including the first medicament, and so forth, for example. In variousembodiments, the cutting member 21380 can be configured to mix the firstmedicament and the second medicament together as the cutting member21380 is advanced through the staple cartridge 21300. In certainembodiments, referring again to FIGS. 93 and 94, the tissue thicknesscompensator 21720 can further comprise one or more channels 21726extending outwardly from each capsule 21724. In various embodiments, thechannels 21726 can be configured to allow the medicaments within thecapsules 21724 to migrate within the tissue thickness compensator 21720,and the tissue T positioned thereagainst, after the capsules 21724 havebeen severed. In various embodiments, the capsules 21724 can beconfigured such that they do not burst when a compressive load isapplied thereto by the anvil 21060. In at least one embodiment,referring primarily to FIGS. 93 and 96, the cartridge body 21710 cancomprise a plurality of recesses 21715 which can each be configured toreceive at least a portion of a capsule 21724 therein. In at least onesuch embodiment, the recesses 21715 can be configured to permit thecapsules 21724 to slide downwardly within the recesses 21715 when acompressive load is applied thereto such that the capsules 21724 may notburst. In various other embodiments, one or more of the capsules 21724could be configured to burst only when a certain compressive forceapplied thereto is met or exceeded. In at least one such embodiment, thecapsules 21724 can be configured to withstand the clamping pressureapplied by the anvil 21060 but may burst when the compressive pressureapplied thereto increases as a result of the cutting member 21380 beingadvanced through the staple cartridge 21700, for example. In at leastone embodiment, the capsules 21724 can include a lubricant therein whichcan facilitate the movement of the cutting member 21380 as it isadvanced and/or retracted within the staple cartridge 21700.

In various embodiments, referring now to FIG. 97, a tissue thicknesscompensator 21820 can comprise a compensator body 21822 and alongitudinal tube 21824 extending therethrough. In at least oneembodiment, similar to the above, the tube 21824 can comprise alongitudinal cavity 21826 defined therein and one or more medicaments21825 positioned within the cavity 21826. In various embodiments, thelongitudinal tube 21824 can further include one or more support legs21827 extending outwardly therefrom which can be configured to supportthe tube 21824. In at least one such embodiment, referring now to FIG.98, the support legs 21827 can support the tube 21824 within a mold21890 while the compensator body 21822 is formed around the tube 21824.In various embodiments, referring now to FIGS. 99 and 100, the materialcomprising the compensator body 21822, such as PGA and/or PCL, forexample, can be poured around the tube 21824 and then lyophilized,foamed, and/or solidified, for example. In at least one embodiment,referring again to FIG. 98, the material comprising the compensator body21822 can be poured into a cavity 21891 surrounding the tube 21824wherein the cavity 21891 can then be closed by a cover 21892. In variousembodiments, referring to FIG. 97, the ends of the support legs 21827may not be covered by the poured material and may be flush with thebottom surface 21821 of the compensator body 21822. In at least oneembodiment, the support legs 21827 and/or the tube 21824 can becomprised of a dissolvable and/or bioabsorbable material, such asgelatin, hyaluronic acid, PDS, and/or ORC, for example. In certainembodiments, the legs 21827 can be rapidly dissolved by bodily fluidsand/or a saline solution, for example, wherein channels or passages canbe left behind that extend between the outer perimeter and the interiorof the tissue thickness compensator 21820. In at least one embodiment,such passages can be created to permit the one or more medicaments 21825positioned within the tube 21824 to be rapidly dissolved and/orabsorbed. An alternative embodiment of a tissue thickness compensator,such as tissue thickness compensator 21920, for example, can comprise acompensator body 21922 and a tube 21924 including a plurality of supportlegs 21927, as illustrated in FIG. 101. In at least one embodiment,referring to FIG. 102, the support legs 21927 can be part of a largersupport network or structural lattice 21928 that can extend through thecompensator body 21922.

In various embodiments, referring again to FIG. 97, the legs 21827extending from the tube 21824 can also include one or more medicamentstherein. When the legs 21827 are dissolved and/or absorbed, as describedabove, the one or more medicaments in the legs 21827 can provide a firstmedicated response to stapled and/or incised tissue while the one ormore medicaments 21825 in the tube 21824 can provide a second, orsubsequent, medicated response, in at least one embodiment. In certainembodiments, referring now to FIGS. 103 and 105, a tissue thicknesscompensator 22020 can comprise a compensator body 22022 and alongitudinal medicament tube 22024 extending through the compensatorbody 22022. Similar to the above, the tube 22024 can define alongitudinal cavity 22026 a including one or more medicaments 22025 apositioned therein. Also similar to the above, the tube 22024 caninclude a plurality of longitudinal leg supports 22027 that can extendalong the length of the tube 22024. In various embodiments, each of theleg supports 22027 can define a longitudinal cavity, such as cavities22026 b and 22026 c, for example, therein which can each include one ormore medicaments, such as medicaments 22025 b and 22025 c, for example,therein. In various embodiments, the leg supports 22027 can be comprisedof a material which can be quickly dissolved and/or absorbed such thatthe medicaments 22025 b and 22025 c can be quickly released. Thereafter,in at least one embodiment, the support legs 22027 and the tube 22024can be further dissolved and/or absorbed such that the medicament 22025a can be subsequently released. In various embodiments, the medicaments22025 a, 22025 b, and/or 22025 c can be comprised of the same material.In other embodiments, the medicaments 22025 a, 22025 b, and/or 22025 ccan be comprised of different materials. In at least one embodiment, themedicaments 22025 b and 22025 c can be comprised of the same material,or materials, which can be different than the material, or materials,comprising medicament 22025 a.

In various embodiments, further to the above, the tube 22024, the legs22027, and/or the cavities 22026 a-22026 c defined therein can bemanufactured utilizing an injection molding process. In certainembodiments, the tube 22024, the legs 22027, and/or the cavities 22026a-22026 c can be manufactured utilizing an extrusion process, forexample, wherein, as a result, such features can comprise a continuouscross-section along the length thereof. As a result of such processes,in various embodiments, the tubes 22024 and the legs 22027 can beintegrally formed. Thereafter, in at least one embodiment, themedicaments 22025 a-22025 c can be positioned within the cavities 22026a-22026 c, respectively. In various embodiments, the medicaments 22025a-22025 c can each be comprised of one or more powders and/or one ormore fluids, for example. In certain embodiments, referring now to FIG.106, the ends 22029 of the cavities 22026 a-22026 c can be sealed inorder to contain the medicaments 22025 a-22025 c therein. In any event,the tube 22024 can then be positioned within a mold, such as the mold21890 described above, for example, wherein the material comprising thecompensator body 22022 can be poured around the tube 22024, asillustrated in FIG. 104, to form the tissue thickness compensator 22020.Various alternative embodiments are illustrated in FIGS. 107 and 108.Referring to FIG. 107, a tissue thickness compensator 22120 can comprisea compensator body 22122 and a plurality of longitudinal tubes 22124which are connected together. In at least one embodiment, each of thetubes 22124 can define a longitudinal cavity 22126 therein which caneach include one or more medicaments 22125 therein. In variousembodiments, the longitudinal cavities 22126 may not be in fluidcommunication with each other while, in some embodiments, one or more ofthe longitudinal cavities 22126 can be in fluid communication with eachother. Similar to the above, the compensator 22120 can further compriselegs 22127 that extend downwardly from the tubes 22124 and can eachinclude a longitudinal cavity 22126 and at least one medicament 22125therein. In various embodiments, the tubes 22124 and/or the support legs22127 can be comprised of materials which can be configured to dissolveand/or biabsorb at different rates. In at least one such embodiment, thesupport legs 22127 can be comprised of a material which can be dissolvedand/or bioabsorbed at a faster rate than the material comprising thetubes 22124, for example. Referring now to FIG. 108, a tissue thicknesscompensator 22220 can comprise a compensator body 22222 and alongitudinal tube 22224 wherein the tube 22224 can include a pluralityof support legs 22227 extending therefrom. In at least one embodiment, asingle longitudinal cavity 22226 can be defined within the tube 22224and can extend into the support legs 22227. Similar to the above, thecavity 22226 can include one or more medicaments 22225 positionedtherein.

In various embodiments, referring again to FIG. 97, the support legs21827 can be comprised of one or materials which can be configured toadsorb a fluid, such as blood and/or a saline solution, for example. Inat least one embodiment, the support legs 21827 can be configured towick the fluid toward the tube 21824 and the one or more medicaments21825 contained therein. In certain embodiments, such wicking can allowthe medicaments 21825 to dissolve and/or bioabsorb earlier in thehealing process. In at least one embodiment, the ends of the supportlegs 21827 may not be covered by the compensator body 21822 and may beexposed to the fluid. In various embodiments, this wicking process canoccur by capillary action and can occur regardless of the orientation ofthe tissue thickness compensator 21820, for example.

In various embodiments, referring now to FIG. 112, a tissue thicknesscompensator 22320 can comprise a compensator body 22322 and a pluralityof tubes 22324 positioned therein. In certain embodiments, thecompensator body 23222 can be comprised of a regenerative tissuescaffold foam, such as an acellular omentum biomatrix, Omentum ScaffoldMaterial, and/or ACell, for example. In at least one embodiment, theOmentum Scaffold Material can comprise a hydrophilic foam produced fromskeletonized omentum and, in certain embodiments, can be compressible.When exposed to a fluid, the Omentum Scaffold Material can expand andapply pressure to the tissue positioned thereagainst. In at least oneembodiment, ACell is a regenerative product that provides anextracellular matrix or scaffolding network to encourage cellularproliferation and migration. In at least one embodiment, the tissuescaffold comprising the compensator body 22322 can be loaded with stemcells, PRP, or growth factors, for example. In at least one embodiment,the tissue scaffold comprising the compensator body 22322 can be coatedin a collagen matrix, for example. In various embodiments, the tissuescaffold matrix of the compensator body 22322 can be comprised of afiber matrix and, in at least one embodiment, the fiber matrix can becomprised of randomly-oriented fibers. In some circumstances, a fibermatrix comprised of randomly-oriented fibers may not be able to providea desired elasticity or resiliency within the compensator body 22322. Toaccount for this, in various embodiments, the randomly-oriented fiberscan be comprised of a hydrophilic material and/or can be coated with ahydrophilic material which, after being exposed to a liquid, can beconfigured to expand and provide a desired resiliency to the fibermatrix and/or a desired compression force to the tissue. In variouscircumstances, the fiber matrix may not be exposed to a liquid untilafter it has been captured against tissue by a plurality of staples, asdescribed above. In at least one such embodiment, the compensator body22322 can comprise a liquid-impermeable wrap which can be broken,punctured, incised, and/or torn, for example, in use to allow the liquidto enter into the compensator body 22322 and access the hydrophilicfibers. In any event, when the liquid is absorbed by the scaffold matrixcaptured within the staples, the scaffold matrix can expand to apply acompressive pressure to the tissue also captured within the staples and,over time, accommodate tissue ingrowth into the scaffold matrix.

In various embodiments, further to the above, the tubes 22324 of thetissue thickness compensator 22320 can be comprised of a degradablematerial which can be configured to dissolve and/or bioabsorb. Similarto the above, each tube 22324 can include a sealed inner cavity havingone or medicaments contained therein and, in addition, one or moresupport legs 22327 which can be configured to degrade and provide achannel or flow path for liquids to reach the medicament stored withinthe tube 22324. Such degradation of the support legs 22327 may take timeand, as a result, the medicament contained within the tubes 22324 maynot be immediately released. In a sense, a period of time may berequired for a fluid to degrade the legs 22327 wherein, as a result, thelegs 22327 can serve as a fuse designed to delay the release of themedicament within the tubes 22324. Thus, in various circumstances, legs22327 having longer lengths and/or thicker cross-sections may provide alonger delay while legs 22327 having shorter lengths and/or thinnercross-sections may provide a shorter delay. In certain embodiments, thetubes 22324 can be comprised of a material which dissolves quicklyand/or slowly; however, in either event, the degradation of the tubes22324 can occur over a period of time which can delay the release of theone or more medicaments contained within the tubes 22324. In variousembodiments, a first tube 22324 can be comprised of a first materialwhich degrades at a first rate and a second tube 22324 can be comprisedof a second material which degrades at a second, or different, rate. Insuch embodiments, a first medicament contained within the first tube22324 can be released before a second medicament contained within thesecond tube 22324, for example. In certain embodiments, a first tube22324 can have a thinner outer wall than a second tube 22324 which canallow the first tube 22324 to degrade faster than the second tube 22324and allow a medicament contained within the first tube 22334 to bereleased before a medicament in the second tube 22324, for example. As aresult of the above, in various embodiments, a first tube 22324 can beconfigured to release a first medicament at a first point in time, asecond tube 22324 can be configured to release a second medicament at asecond, or later, point in time, and a third tube 22324 can beconfigured to release a third medicament at a third, or even later,point in time, for example.

In various embodiments, referring now to FIGS. 113 and 114, a tissuethickness compensator 22420 can comprise a compensator body 22422 and asealed vessel 22424 positioned within the compensator body 22422. In atleast one embodiment, similar to the above, the vessel 22424 can definea longitudinal cavity 22426 and one or more medicaments 22425 positionedwithin the longitudinal cavity 22426. In certain embodiments, the vessel22424 can be resilient such that, when the tissue thickness compensator22420 is compressed, or flattened, as illustrated in FIG. 114, thevessel 22424 can seek to spring back or retain its original, undeformedshape. In at least one such embodiment, the vessel 22424 can comprise anelastic spring member positioned within the compensator body 22422. Inat least one embodiment, the vessel 22424 can be configured to changeshape without rupturing. In at least one such embodiment, the vessel22424 can degrade when exposed to a liquid, for example, as describedherein.

In various embodiments, referring now to FIG. 115, a tissue thicknesscompensator 22520 can comprise a compensator body 22522 and a pluralityof sealed vessels 22524 a-22524 c. In at least one embodiment, each ofthe vessels 22524 a-22524 c can define an outer perimeter which isconfigured to increase, maximize, and/or optimize the surface area ofthe vessel that comes into contact with a liquid, such as blood and/or asaline solution, for example. In various circumstances, vessels having alarger surface area may be exposed to a larger quantity of liquid and,as a result, can be dissolved and/or bioabsorbed at a faster rate.Correspondingly, vessels having a smaller surface area may be exposed toa smaller quantity of liquid and, as a result, can be dissolved and/orbioabsorbed at a slower rate. In various embodiments, the vessels 22524a-22524 c can be comprised of gelatin, hyaluronic acid, PDS, and/or ORC,for example. Similar to the above, in certain embodiments, the vessels22524 a-22524 c can be resilient and can provide a spring-back orelastic biasing force. In various embodiments, referring now to FIG.116, a tissue thickness compensator 22620 can comprise a compensatorbody 22622 and a plurality of resilient laminate members 22624positioned within the compensator body 22622. In at least oneembodiment, each of the laminate members 22624 can comprise a sealedinner channel including one or more medicaments positioned therein.

In various embodiments, referring now to FIG. 117, an end effector of asurgical stapling instrument can comprise an anvil 21060 and a staplecartridge 22700. In at least one embodiment, the anvil 21060 cancomprise a tissue thickness compensator 22770 attached thereto and thestaple cartridge 22700 can comprise a cartridge body 22710 and a tissuethickness compensator 22720. In certain embodiments, referring now toFIG. 118, the tissue thickness compensator 22770 can comprise aplurality of layers wherein, in at least one embodiment, the tissuethickness compensator 22720 can comprise a first layer 22771 and asecond layer 22772, although other embodiments are envisioned in which atissue thickness compensator can comprise more than two layers. Invarious embodiments, one or more of the layers of the tissue thicknesscompensator can comprise a woven material. In at least one embodiment,the first layer 22771 can be comprised of a plurality of first threads22773 comprised of a first material and a plurality of second threads22774 comprised of a second, or different, material. Similarly, thesecond layer 22772 can be comprised of a plurality of first threads22773 and a plurality of second threads 22774. In certain embodiments,the concentrations of the first threads 22773 and the second threads22774 in the first layer 22771 can be the same as the concentrations ofthe first threads 22773 and the second threads 22774 in the second layer22772. In certain other embodiments, the concentrations of the firstthreads 22773 and the second threads 22774 in the first layer 22771 canbe different than the concentrations of the first threads 22773 and thesecond threads 22774 in the second layer 22772, as discussed in greaterdetail below.

In various embodiments, further to the above, the first threads 22773can be comprised of bioabsorbable polymer, such as PGA, PDS, PCL, and/orPLA, for example, and the second threads 22774 can be comprised ofoxidized regenerated cellulose (ORC), for example. In certainembodiments, the first layer 22771 can comprise an outer layer of thetissue thickness compensator 22770 and can include a tissue contactingsurface. In at least one embodiment, the first layer 22771 can comprisemore first threads 22773 than second threads 22774. In at least one suchembodiment, the first layer 22771 can comprise a ratio of approximately80% first threads 22773 to approximately 20% second threads 22774, forexample. In various embodiments, the first layer 22771 can comprise aratio of approximately 60% first threads 22773 to approximately 40%second threads 22774, a ratio of approximately 67% first threads 22773to approximately 33% second threads 22774, a ratio of approximately 70%first threads 22773 to approximately 30% second threads 22774, a ratioof approximately 75% first threads 22773 to approximately 25% secondthreads 22774, and/or a ratio of approximately 90% first threads 22773to approximately 10% second threads 22774, for example.

In various embodiments, further to the above, the first threads 22773can be comprised of a material which dissolves, bioabsorbs, and/orchanges state at a slower rate than the material comprising the secondthreads 22774. In at least one such embodiment, the second threads 22774can be comprised of ORC threads which can change from a solid to a gelwhen they are exposed to a liquid, for example, and, in at least oneembodiment, the ORC threads can react and change from a solid to a gelwhen they are exposed to platelets, for example. In such embodiments,however, the first layer 22773 can be mostly comprised of bioabsorbablepolymer threads which can react to liquids much slower than the ORCthreads and, thus, in at least one embodiment, the first layer 22773 cancome into contact with tissue or bodily fluids on multiple occasionswithout losing its overall shape and structure. That said, the ORCfibers in the first layer 22773 can react when they first come intocontact with a liquid and/or tissue; however, the ORC gel can be atleast partially or mostly retained within the first layer 22773.

In various embodiments, the second layer 22772 can comprise an innerlayer of the tissue thickness compensator 22770 and may not include adirect tissue contacting surface. In at least one embodiment, the secondlayer 22772 can comprise less first threads 22773 than second threads22774. In at least one such embodiment, the second layer 22772 cancomprise a ratio of approximately 20% first threads 22773 toapproximately 80% second threads 22774, for example. In variousembodiments, the second layer 22772 can comprise a ratio ofapproximately 40% first threads 22773 to approximately 60% secondthreads 22774, a ratio of approximately 33% first threads 22773 toapproximately 67% second threads 22774, a ratio of approximately 30%first threads 22773 to approximately 70% second threads 22774, a ratioof approximately 25% first threads 22773 to approximately 75% secondthreads 22774, and/or a ratio of approximately 10% first threads 22773to approximately 90% second threads 22774, for example.

In various embodiments, further to the above, the second layer 22772 cancomprise more ORC threads than bioabsorbable polymer threads, forexample. In certain embodiments, the second layer 22772 can comprisemore ORC threads than the first layer 22771. As the second layer 22772is not an outer layer, in various embodiments, liquids may notimmediately contact the second layer 22772 as they would have to firstpass through the first layer 22771 before contacting the second layer22772. In such embodiments, the second layer 22772 can comprise a higherdensity of ORC threads as the ORC threads in the second, protected,layer 22772 would not immediately turn into a gel. Even if the ORCthreads in the second layer 22772 were to come into contact with aliquid and turn into a gel, the ORC gel could be contained in the tissuethickness compensator 22770 by the first layer 22771 which, as describedabove, can maintain its general shape, at least initially, and provide asupport mesh to the second layer 22772. While ORC fibers andbioabsorbale fibers can be utilized in various embodiments, othersuitable materials could be utilized.

Further to the above, referring now to FIGS. 121-123, the tissuethickness compensator 22770 can be positioned intermediate an anvil21060 and tissue T, wherein the tissue thickness compensator 22770 canbe compressed against the tissue T before staples 21330 are fired fromthe staple cartridge 22700. After the staples 21330 have been fired tocapture the tissue T and the tissue thickness compensators 22720 and22770 therein, the anvil 21060 and the cartridge body 22710 of thestaple cartridge 22700 can be moved away from the compensators 22720,22770 and the tissue T and removed from the surgical site. In variousembodiments, referring now to FIG. 119, a layer 22871 of a tissuethickness compensator can comprise woven threads 22873 which can includean elongate, or flattened, cross-section, for example. In certainembodiments, referring now to FIG. 120, a layer 22971 of a tissuethickness compensator can comprise woven threads 22973 which can includea round cross-section, for example.

Various alternative embodiments are illustrated in FIGS. 124-127.Referring now to FIG. 125, an end effector of a surgical staplinginstrument can include an anvil 21060 and a tissue thickness compensator22770′ positioned thereon. In various embodiments, referring to FIG.124, the tissue thickness compensator 22270′ can comprise a layer 22771′which can include a plurality of first fibers 22773′ woven with aplurality of second fibers 22774′. In at least one such embodiment, thefirst fibers 22773′ can be configured to dissolve and/or bioabsorb at afaster rate than the second fibers 22774′. In certain embodiments, gaps,openings, and/or pockets can be defined between the first fibers 22773′and the second fibers 22773″ which can permit liquids to flow throughthe layer 22771′. Referring now to FIG. 127, an end effector of asurgical stapling instrument can include a tissue thickness compensator22770″ attached to an anvil 21060. In various embodiments, referring toFIG. 126, the tissue thickness compensator 22770″ can comprise a wovenlayer of threads 22771″ which can be embedded and/or encased within asubstrate 22772″. In at least one embodiment, the threads 22771″ can beexposed while, in other embodiments, at least a portion of the substrate22772″ may have to be dissolved and/or bioabsorbed before the threads22771″ are exposed. In at least one such embodiment, the materialcomprising the substrate 22772″ may fill within any gaps, openings, orpockets defined between the threads 22771″.

In various embodiments, referring now to FIG. 132, a staple cartridge23000 can include a tissue thickness compensator 23020. As discussedherein, a tissue thickness compensator can be manufactured utilizing alypholization process, for example. In at least one embodiment, asolution comprising PGA and/or PCL, for example, can be poured into amold wherein the solution can be permitted to grow into an open cellfoam in the presence of a vacuum atmosphere and/or reduced temperature,for example. In at least one such embodiment, the PGA material can bepresent in the solution according to an approximately 64/36 ratio byweight with respect to the PLA material, for example. In variousembodiments, referring to FIG. 128, fibers and/or filaments 23021, forexample, can be mixed into the solution. In at least one embodiment, PGAfibers, for example, can be dispersed within the solution before it ispoured into the mold such that the PGA fibers can be evenly, or at leastsubstantially evenly, distributed throughout the tissue thicknesscompensator 23020, for example. In other circumstances, the PGA fiberscan be placed in the solution, and/or directly into the mold, forexample, such that the PGA fibers can precipitate or settle toward thebottom of the mold, for example. In other circumstances, the PGA fiberscould be configured to float to the top of the solution. In any event,in certain embodiments, a solvent, such as dioxane solvent, for example,can be present in the solution which can assist in the lypholizationprocess. In various embodiments, the dioxane solvent may not react, orat least substantially react, with the PGA fibers within the solution.

In various embodiments, further to the above, the fibers 23021 can becoated with one or more medicaments before they are mixed into and/orwith the solution. In certain embodiments, referring to FIG. 130, eachfiber 23021 can comprise a substrate 23022 which can be at leastpartially coated with a coating 23023 utilizing any suitablemanufacturing process. Referring to FIG. 129 the fibers 23021 can bemanufactured utilizing an extruding process in which at least one drugcoating is placed on a PGA substrate, for example. Such embodiments maybe particularly useful for drugs that can withstand the elevatedtemperature of an extruding process. Referring to FIG. 131, the fibers23021 can be coated and/or impregnated with a drug utilizing a carrierfluid, such as supercritical carbon dioxide, for example. In any event,in various embodiments, the drug-coated fibers 23021 can be mixed withthe solution such that the fibers 23021 become embedded within thetissue thickness compensator 23020. In various circumstances, as aresult, the coatings of the fibers 23021 may begin to dissolve and eludethe one or more medicaments contained therein. In certain embodiments,the fibers 23021 positioned closer to the perimeter of the tissuethickness compensator 23020 may begin to dissolve before the fibers23021 positioned closer to the interior of the tissue thicknesscompensator 23020. In such embodiments, the dissolved fibers 23021 mayleave behind a plurality, or network, of cavities within the tissuethickness compensator 23020 wherein, in at least one embodiment, suchcavities can permit cellular or tissue ingrowth within the tissuethickness compensator 23020. In certain embodiments, a tissue thicknesscompensator can comprise a plurality of first fibers which can dissolveat a faster than a plurality of second fibers.

In at least one such embodiment, the first fibers can comprise PGAfibers, for example, which have been gamma irradiated. In variousembodiments, gamma irradiated PGA fibers can dissolve faster thannon-gamma irradiated PGA fibers, for example.

In various embodiments, one or more colorants can be added to thesolution described above such that the tissue thickness compensatorproduced from the solution can have a suitable color. In at least oneembodiment, it may be desirable for the tissue thickness compensator tohave a color which contrasts with its surrounding environment. In atleast one such embodiment, the tissue thickness compensator can be greenand/or blue, for example.

In various embodiments, referring now to FIGS. 133 and 135, a tissuethickness compensator 23120 can comprise a compensator body 23122 and aplurality of medicament particles 23121 distributed throughout thecompensator body 23122. In at least one embodiment, the compensator body23122 can be comprised of a hydrophobic material. In at least one suchembodiment, the compensator body 23122 can be comprised of a materialincluding PCL/PGA, for example, wherein the PCL and PGA can be presentin the material according to a 65/35 ratio by weight. In certainembodiments, referring now to FIG. 134, the medicament particles 23121can comprise one or more drugs 23123, such as doxycycline, percarbonate,and/or ascorbic acid phosphate, for example, which can be encapsulatedby and/or incorporated within a casing or shell 23124 comprised of ahydrophilic material, for example. In at least one embodiment, the shell23124 can be comprised of low molecular weight gelatin, hyaluronic acid,and/or CMC, for example. In various embodiments, the medicament 23121can be manufactured as micro-particles which can be distributed within asolution and poured into a mold where the solution can be subsequentlylyophilized, for example, as described above. Once the tissue thicknesscompensator 23120 has been exposed to a liquid, in use, a fluid 23129(FIG. 136) can enter into the compensator body 23122 and dissolve and/orabsorb the hydrophilic shell 23124 of the medicament particles 23121,for example. In various embodiments, referring now to FIG. 139, a tissuethickness compensator 23220 can comprise a first layer 23222 and asecond, or outer, layer 23224 which, in at least one embodiment, cancomprise a plurality of coated drug particles 23221 dispersed therein.Similar to the above, the particles 23221 can be dissolved and/orabsorbed from the second layer 23224 and can leave behind openings orcapillary paths 23225, for example, within the second layer 23224, forexample. In certain embodiments, referring now to FIG. 140, a tissuethickness compensator 23320 can comprise a compensator body 23322comprising a plurality of medicament particles 23121 and a plurality offibers 23021 distributed therein, for example.

In various embodiments, referring now to FIGS. 141 and 142, a staplecartridge 23400 can include a cartridge body 23410 and a tissuethickness compensator 23420 positioned thereon, for example. In at leastone embodiment, the tissue thickness compensator 23420 can comprise aplurality of capsules 23421 positioned within the compensator body23422. In certain embodiments, the capsules 23421 can be manufacturedutilizing an emoulism, or spin disk, process, for example, and, in atleast one embodiment, the capsules 23421 can comprise microspheres ofsolid and/or liquid biometrics, for example. In various embodiments, thecapsules 23421 can include one or more adhesives which, when releasedfrom the capsules 23421, can help secure tissue sealing. Certainembodiments are envisioned in which the capsules 23421 can includehaemostatic agents, for example. In any event, in various embodiments,the capsules 23421 can be distributed within the compensator body 23422in any suitable manner. In at least one embodiment, referring now toFIG. 143, the capsules 23421 can be placed in a mold cavity 21891defined in a mold 21890, for example, wherein the capsules 23421 cansettle to the bottom 21893 of the mold 21890. In certain embodiments,referring to FIG. 144, the mold 21890 can be vibrated such that thecapsules 23421 can form an even, or an at least substantially even,layer on the bottom 21893. In various embodiments, referring now to FIG.145, the material comprising the compensator body 23422 can be pouredinto the mold cavity 21891 with the capsules 23421. In certainembodiments, the capsules 23421 can be denser than the compensator bodymaterial and, as a result, the capsules 23421 may remain at the bottom21893 of the mold 21890 as illustrated in FIG. 146. In at least one suchembodiment, referring to FIG. 148, the bottom 21893 of the mold 21890can include a plurality of recesses, depressions, and/or dimples 21899which can be configured to receive the capsules 23421. In certain otherembodiments, referring to FIG. 147, the capsules 23421 can be less densethan the compensator body material and may float to the top of the mold21890. In various embodiments, as described in greater detail furtherbelow, the density of the capsules 23421 can be selected such that thecapsules 23421 can float throughout the compensator body material.

After the mixture comprising the capsules 23421 and the compensator bodymaterial has been suitably poured into the mold 21890, the mixture canundergo a lypholization process, for example, to form the tissuethickness compensator 23420. In at least one such embodiment, thecapsules 23421 can be secured or freeze-dried into position within thecompensator body 23422. Thereafter, referring again to FIG. 141, thetissue thickness compensator 23420 can be removed from the mold 21890and then assembled to the cartridge body 23410 of the staple cartridge23400. As illustrated in FIG. 141, the tissue thickness compensator23420 can be positioned and arranged such that capsules 23421 candefine, or are positioned adjacent to, a tissue-contacting surface, orskin, 23425 of the tissue thickness compensator 23420. In certainembodiments, the capsules 23421 can be at least partially comprised of ahydrophilic material, for example, which can be quickly dissolved and/orbioabsorbed after the tissue thickness compensator 23420 has beenpositioned against tissue, for example. In at least one embodiment, eachof the capsules 23421 can be comprised of multiple layers of materialswhich can be dissolved and/or bioabsorbed over time. In at least onesuch embodiment, an outer layer of a capsule 23421 can comprise a firstmedicament which can be dissolved and/or bioabsorbed to expose a second,or inner, layer comprising a second medicament which can then bedissolved and/or bioabsorbed, for example. In at least one embodiment,some of the capsules 23421 can be positioned such that they are incisedby a cutting member, described elsewhere herein, as the cutting memberis progressed distally to incise the tissue and/or the tissue thicknesscompensator 23420. In at least one embodiment, the capsules 23421 candecrease the density of the tissue thickness compensator 23420 which canreduce the force or energy needed to advance the cutting member throughthe tissue thickness compensator 23420, for example.

As discussed above, various embodiments of a tissue thicknesscompensator 23420 can comprise capsules 23421 positioned on one or moresides, or skins, on the compensator body 23422. As also discussed above,certain embodiments of a tissue thickness compensator 23420 can comprisecapsules 23421 dispersed throughout the compensator body 23422. In atleast one such embodiment, the capsules 23421 can have the same densityof the compensator body material such that the capsules 23421 can floatwithin the compensator body material. In certain embodiments, thecapsules 23421 can be dispersed, or homogenized, throughout thecompensator body material wherein the mixture can then be cooled beforethe capsules 23421 settle, or at least substantially settle, to thebottom of the mold.

In various embodiments, referring now to FIG. 149, a tissue thicknesscompensator 23520 can comprise a shell 23522 and a plurality of movableelements 23524 positioned within the shell 23522. In at least oneembodiment, the shell 23322 can define an enclosed and/or sealed space,such as cavity 23523, for example, within which the movable elements23524 can move. In certain embodiments, the movable elements 23254 canbe spherical in shape, for example, and can be configured to slideand/or roll, for example, relative to each other. In variousembodiments, the tissue thickness compensator 23520 can be positionedover a cartridge body 21310 of a staple cartridge wherein staples 21330can be fired from the staple cartridge and through the tissue thicknesscompensator 23520, as illustrated in FIG. 150. In various circumstances,the movable elements 23524 can be configured to move to the sides of thestaples 21330 being fired through the tissue thickness compensator 23520such that the elements 23524 may not be ruptured during the firingprocess. In at least one such embodiment, the shell 23522 can becomprised of a resilient material which can be configured to flex and/orshift in order to accommodate the movement of the movable elements 23524and dynamically redistribute the forces generated within. In certainembodiments, the shell 23522 can enclose a medium. In at least one suchembodiment, the medium can comprise one or more powders, liquids,gasses, fluids, and/or gels, for example, within which the movableelements 23524 can move. In various embodiments, the movable elements23524 can be comprised of a dissolvable and/or bioabsorbable material,for example, and one or more medicaments contained therein. In at leastone such embodiment, such an arrangement can be configured to provide adelayed and/or sustained release of the one or more medicaments. Incertain alternative embodiments, although not illustrated, the tissuethickness compensator 23520 can be positioned between the tissue T andan anvil 21060, for example. In any event, in various embodiments, thetissue thickness compensator 23520 can comprise an enclosed “bean bag”arrangement. In certain embodiments, the shell 23522 can be configuredsuch that it does not rupture, or at least substantially rupture, untila cutting member, such as cutting member 21380, for example, is passedtherethrough. At such point, in various embodiments, one or more of themovable elements 23524 could escape from the shell 23522.

In various embodiments, referring now to FIG. 153, a tissue thicknesscompensator 23620 can comprise a compensator body 23622 and a pluralityof capsules 23624 at least partially contained therein. In certainembodiments, referring now to FIG. 151, a mold 23690 can be utilized tomanufacture the tissue thickness compensator 23620. In at least one suchembodiment, a plurality of spherical capsules 23624 can be positionedwithin a cavity 23691 defined in the mold 23690 wherein the lateralmovement of the capsules 23624 within the mold 23690 can be arrested orstopped by lateral sidewalls 23694 of the mold 23690 and lateral stops23693 extending between the lateral sidewalls 23694, for example. Invarious embodiments, the lateral sidewalls 23694 and the lateral stops23693 can define a plurality of pockets within which the capsules 23624can be positioned and contained. In certain embodiments, the capsules23624 can be configured to rest on the bottom surface 23699 of the mold23690. In other embodiments, referring to FIGS. 151 and 152, the mold23690 can further comprise one or more longitudinal supports 23692 whichcan be configured to suspend the capsules 23624 such that they are notin contact with the bottom surface 23699 of the mold 23690. In at leastone such embodiment, the longitudinal supports 23692 can be positionedon the bottom surface 23699 while, in other embodiments, referring toFIG. 152, the longitudinal supports 23692 can be positioned on thelateral supports 23693.

In various embodiments, referring again to FIGS. 151 and 152, a materialcomprising the compensator body 23622 can be poured into the cavity23691 of the mold 23690 such that the capsules 23624 are at leastsubstantially surrounded by the material. In at least one embodiment,referring primarily to FIG. 153, portions of the capsules 23624 canprotrude from the compensator body 23622 of a tissue thicknesscompensator 23620. In certain embodiments, the lateral supports 23693and/or the longitudinal supports 23692 can be withdrawn from the mold23691 during and/or after the compensator body 23622 has undergone alypholization process, for example. At such point, the capsules 23624can be suspended within the compensator body 23622 without structuralsupports. In various other embodiments, the lateral supports 23693and/or the longitudinal supports 23692 can remain in the compensatorbody 23622. In at least one such embodiment, the lateral supports 23693and/or the longitudinal supports 23692 can be comprised of abioabsorbable material, for example. In certain embodiments, thesupports 23692 and/or the supports 23693 can comprise elastic memberspositioned within the compensator body 23622 which can increase theresiliency of the compensator body 23622, for example.

In various embodiments, referring now to FIG. 157, a tissue thicknesscompensator 23720 can comprise a compensator body having first andsecond portions, 23722 a and 23722 b, and at least one capsule 23724positioned therebetween. In at least one embodiment, the tissuethickness compensator 23720 can be manufactured utilizing mold 21890,for example. Referring now to FIG. 154, a first material can be pouredinto the mold 21890 to form the first portion 23722 a of the compensatorbody. Thereafter, referring to FIG. 155, the capsule 23724 can bepositioned on the first portion 23722 a. In some embodiments, thecapsule 23724 can be positioned on the first portion 23722 a after aperiod of time and/or after the first material has undergone alypholization process, for example. Referring now to FIG. 156, a secondmaterial can be poured into the mold 21890 to form the second portion23722 b of the compensator body. After a period of time and/or after thesecond material has undergone a lypholization process, for example, thetissue thickness compensator 23720 can be removed from the mold 21890and used in connection with a staple cartridge 23700 as illustrated inFIG. 158, for example. In certain embodiments, the second material canbe different than the first material while, in other embodiments, thesecond material can be the same as the first material. In either event,in various embodiments, the first material and/or the second materialcan be comprised of a bioabsorbable material and the capsule 23724 canbe comprised of at least one medicament, for example.

In various embodiments, referring now to FIG. 162, a staple cartridge23800 can comprise a tissue thickness compensator 23820 which caninclude a compensator body 23822 and a longitudinal capsule 23824positioned therein. In at least one embodiment, referring now to FIGS.159 and 160, a longitudinal aperture 23821 can be formed in thecompensator body 23822 by any suitable process such as by a mechanicaldrilling process and/or a laser drilling process, for example. Once thelongitudinal aperture 23821 has been formed, a longitudinal capsule23824 can be positioned within the longitudinal aperture 23821, asillustrated in FIG. 161. In various embodiments, referring now to FIG.166, a staple cartridge 23900 can comprise a tissue thicknesscompensator 23920 which can include a compensator body 23922 and aplurality of transverse capsules 23924 positioned therein. In at leastone embodiment, referring now to FIGS. 163 and 164, transverse apertures23921 can be formed in the compensator body 23922 by any suitableprocess such as by a mechanical drilling process and/or a laser drillingprocess, for example. Once the transverse apertures 23921 have beenformed, a plurality of transverse capsules 239824 can be positionedwithin the transverse apertures 23921, as illustrated in FIG. 165.

FIGS. 167-171 illustrate an alternative method for manufacturing thetissue thickness compensator 23820 utilizing a vertical mold 24090.Referring primarily to FIG. 167, the mold 24090 can include a cavity24091 defined by sidewalls 24092 and a bottom end wall 24093. In atleast one embodiment, referring to FIG. 168, the end wall 24093 cancomprise an aperture 24094 which can be configured to receive an end ofthe longitudinal capsule 23824 and hold the capsule 23824 in an uprightposition, as illustrated in FIG. 169. Thereafter, referring now to FIG.170, the open side of the cavity 24091 can be closed and/or sealed by acover 24095 such that the material comprising the compensator body 23822can be poured into the cavity 24091 through an open end of the mold24090. After the material comprising the compensator body hassolidified, cured, and/or lyophilized, for example, the tissue thicknesscompensator 23820 can be removed from the mold 24090.

In various embodiments, referring now to FIG. 172, a staple cartridge24100 can comprise a cartridge body 24110, a tissue thicknesscompensator mat 24170 positioned against a deck surface 24111 of thecartridge body 24110, and a tissue thickness compensator 24120positioned on top of the tissue thickness compensator mat 24170. In atleast one embodiment, the tissue thickness compensator 24120 and thetissue thickness compensator mat 24170, together or independently, cancompensate for variations in the thickness of the tissue captured withinstaples, such as staples 21330 (FIG. 175), for example, fired from thestaple cartridge 24100. In various embodiments, referring primarily toFIGS. 172 and 173, the compensator mat 24170 can comprise a bottomsurface 24171 configured to abut the deck surface 24111 and, inaddition, an attachment flange or rail 24174 extending from the bottomsurface 24171 which can be configured to be securely received within aknife slot 24114 defined in the cartridge body 24110. The compensatormat 24170 can further comprise a plurality of packets 24172 which canextend transversely across the compensator mat 24170. In at least onesuch embodiment, each of the packets 24172 can be defined along atransverse axis which is transverse to and/or perpendicular to alongitudinal axis defined by the knife slot 24114, as illustrated inFIG. 176. In various embodiments, the compensator mat 24170 can comprisea plurality of layers between which the packets 24172 can be defined. Inat least one such embodiment, the layers can be comprised of PDS and/orcollagen, for example. In at least one embodiment, each packet 24172 canbe configured to store one or more medicaments therein such asdoxycycline, a coagulant, and/or an anti-microbial material, forexample.

Referring again to FIG. 175, the tissue thickness compensator mat 24170can be positioned relative to the cartridge body 24110 such that thepackets 24172 overlie the staple cavities 21312 defined in the cartridgebody 24110. More particularly, in at least one embodiment, each packet24172 can be positioned and arranged such that it extends between thestaples legs 21332 of a staple 21330. In various embodiments, thecompensator mat 24170 can comprise a plurality of apertures and/orthroughholes which can be configured to receive the ends of the staples21330, for example. These throughholes can be positioned adjacent to thepackets 24172, for example. As the staples 21330 are moved from anunfired position to a fired position, as illustrated in FIG. 175, thestaples 21330 can be configured to capture the packets 24172 therein. Inat least one such embodiment, the staples 21330 and the packets 24172can be configured and arranged such that the packets 24172 are notpunctured or ruptured while the staples 21330 are being fired. In suchembodiments, the packets 24172 can provide a resilient or compressivepressure to the tissue T captured within the staples 21330 and canconsume gaps between the tissue T and the staples 21330, for example. Invarious embodiments, referring again to FIG. 176, the packets 24172 canbe incised by the cutting member 21380 as the cutting member 21380 isadvanced through the knife slot 24114 defined in the cartridge body24110, the tissue T, and/or the compensator mat 24170. The reader willnote that the tissue thickness compensator 24120 is not depicted inFIGS. 175 and 176. Various embodiments are envisioned in which thestaple cartridge 24100 includes the tissue thickness compensator mat24170 and not the tissue thickness compensator 24120 while, in otherembodiments, referring now to FIG. 177, the staple cartridge 24100 caninclude both the tissue thickness compensator mat 24170 and the tissuethickness compensator 24120, for example.

An alternative embodiment of a staple cartridge is illustrated in FIG.178. In various embodiments, a circular staple cartridge 24200 cancomprise a circular cartridge body 24210 including a plurality of staplecavities 21312 arranged in concentric circles, for example. In at leastone such embodiment, the staple cartridge 24200 can further comprise acircular tissue thickness compensator mat 24270 positioned on thecartridge body 24210 wherein the compensator mat 24270 can comprisepackets 24272 which extend radially outwardly, for example. In certainembodiments, similar to the above, the packets 24272 can extend indirections which overlie the staple cavities 21312 such that the packets24272 can extend between the legs of staples 21330 positioned within thestaple cavities 21312. Also similar to the above, the staples 21330 canbe configured to capture the packets 24272 therein when the staples21330 are fired from the staple cartridge 24200.

In various embodiments, referring now to FIG. 189, a staple cartridge24300 can include a cartridge body 24310 and a tissue thicknesscompensator 24320 including a compensator body 24322 and a plurality oftubular members 24324 positioned within the compensator body 24322. Inat least one such embodiment, the staple cartridge 24300 can furthercomprise a tissue thickness compensator layer, or sheet, 24370, forexample, positioned intermediate the tissue thickness compensator 24320and the cartridge body 24310. In certain embodiments, referring now toFIG. 179, a plurality of staple cartridges 24300 can be manufacturedsimultaneously utilizing a mold 24390. The mold 24390 can include aplurality of cavities 24391 which can each be configured to receive acartridge body 24310 therein, as illustrated in FIG. 180. Thereafter,one or more large sheets of material comprising the tissue thicknesscompensator layer 24370 can be placed over the cartridge bodies 24310.In at least one embodiment, the mold 24390 can include a plurality ofupwardly-extending support pins or posts 24392 wherein the sheets 24370can be positioned against the posts 24392 and then pushed downwardlysuch that the posts 24392 can puncture the sheets 24370 as illustratedin FIGS. 181 and 183. In various embodiments, referring now to FIGS. 182and 184, an elongate tube, or tubes, 24324 can be wound around andbetween the posts 24392 such that the tube 24324 passes over eachcartridge body 24310 at least once. In at least one embodiment, the tube24324 can be wound around and between the posts 24392 such that the tube24324 passes over each cartridge body 24310 six times, for example. Incertain embodiments, the tube 24324 can be permitted to rest on thesheets 24370 while, in certain other embodiments, the tube 24324 can bewound tightly around and between the posts 24392 such that the tube24324 is taut and can be suspended above the sheets 24370. Once the tube24324 has been suitably positioned, referring primarily to FIG. 185, amaterial comprising the compensator body 24322 can be poured into themold 24390 on top of the sheets 24370. In at least one embodiment, thesheets 24370 can be configured to protect, or mask, the cartridge bodies24310 and can prevent the compensator body material 24322 from enteringinto the staple cavities 21312 defined in the cartridge bodies 24310,for example. In various embodiments, a sufficient amount of compensatorbody material 24322 can be poured into the mold such that thecompensator body material 24322 covers the elongate tube 24322.

In various embodiments, further to the above, the compensator bodymaterial 24322 can then be cured, solidified, and/or lyophilized, forexample, to form the tissue thickness compensators 24320 on top of thecartridge bodies 24310. Thereafter, in at least one embodiment,referring now to FIG. 186, a cutting die 24395 can be utilized to cutthe compensator body material 24322, the tissue thickness compensatorsheets 24370, and the elongate tube 24322. In various embodiments,referring now to FIG. 187, the cutting die 24395 can comprise aplurality of cutting blades 24396 which can be configured to singulateand detach the tissue thickness compensators 24320 and the tissuethickness compensator sheets 24370 from one another. In certainembodiments, the cutting die 24395 can include a plurality of wells24397 which can be configured to remove any excess material between thesingulated tissue thickness compensators 24320 and the tissue thicknesscompensator sheets 24370, as illustrated in FIG. 188. In variousembodiments, the cutting die 24935, and/or any other suitable die, cancomprise one or more heating elements, for example, which can beconfigured to seal the ends and/or edges of the tissue thicknesscompensators 24320. In at least one embodiment, the tube 24324 can befilled with one or more fluids. In such embodiments, the cutting blades24396 can be configured to incise the tube 24324 and, at the same time,seal the ends of the tube portions contained within the tissue thicknesscompensator 24320. Thereafter, the plurality of staple cartridges 24300can be removed from the mold.

In various embodiments, referring now to FIGS. 190 and 191, a staplecartridge 24400 can comprise a cartridge body 24410 which can beconfigured to removably store a plurality of staples therein. Inaddition, the staple cartridge 24400 can further comprise a tissuethickness compensator 24420. In at least one embodiment, the tissuethickness compensator 24420 can include a compensator body comprised ofa plurality of layers 24422 wherein, in various embodiments, the layers24422 can be comprised of cellulose film, for example. As illustrated inFIG. 192, in various embodiments, a material 24424 can be positionedbetween two or more adjacent layers 24422 wherein the material 24424 canspace the adjacent layers 24422 apart from each other. In at least oneembodiment, the material 24424 can comprise a polyblend biomedicsextrusion and, in various embodiments, the material 24424 can comprise ahaemostatic material, an anti-inflammatory material, and/or ananti-biotic material, for example. In certain embodiments, referring nowto FIG. 192, the material 24424 can be applied to a layer 24422 by adispenser 24490 in a wave pattern, for example, wherein the wave patterncan be configured such that the material 24424 can be positioned overone or more staple cavities defined in the cartridge body 24410. In suchembodiments, the material 24424 can be captured within staples ejectedfrom the staple cavities and provide a resilient biasing force to tissuealso captured within the staples. In any event, one or more of thelayers 24422 can be vacuum formed and/or heat sealed, for example, overthe material 24424 to create the tissue thickness compensator 24420. Incertain embodiments, the tissue thickness compensator 22420 can then becut to length. Various embodiments are envisioned in which a tissuethickness compensator 22420 is positioned against the deck surface of astaple cartridge and another tissue thickness compensator 22420 ispositioned against the anvil.

In certain embodiments, referring now to FIG. 195, a staple cartridge24600 can comprise one or more tissue thickness compensators 24620positioned over a cartridge body 24610. Referring primarily to FIG. 194,each tissue thickness compensator 24620 can comprise a plurality oflayers 24622 and a compressible, or collapsible, member 24624 positionedbetween the layers 24622. In various embodiments, the collapsible member24624 can comprise a corrugated member which includes a plurality ofpockets defined therein wherein, in at least one embodiment, one or moremedicaments can be stored within the pockets. In at least one suchembodiment, a first medicament can be placed within the pockets on afirst side of the corrugated member and a second medicament can beplaced within the pockets on a second side of the corrugated member, forexample. In certain embodiments, the tissue thickness compensator 24620can be formed when the layers 24622 and the compressible member 24624are compressed together by rollers 24590, for example. With referencenow to an embodiment depicted in FIG. 193, a tissue thicknesscompensator 24520 can be formed from a tube of material that is rolledinto a partially flattened shape by rollers 24590, for example. Invarious embodiments, referring now to FIGS. 196 and 197, staples 21330positioned within the cartridge body 24610 can be ejected therefrom suchthat the staples 21330 can capture at least a portion of a tissuethickness compensator 24620 therein. In such embodiments, thecompressible member 24624 can be configured to apply a resilient biasingforce against the tissue T which has also been captured within thestaples 21330. In various embodiments, the layers 24622 of the tissuethickness compensator 24620 can also be configured to apply a resilientbiasing force against the tissue T. In certain embodiments, the staples21330 can puncture the pockets of the corrugated member 24624 andrelease the one or more medicaments contained therein.

The tissue thickness compensators described above may include substancestherein. The substances may include coagulants, medications, and/oranti-inflammatories, for example. The substances may be liquids, butalso may take other forms, such as solids and/or gels, for example. Forsurgical devices that include such tissue thickness compensators, it maybe advantageous for the surgical device to include features that directthe substance out of the tissue thickness compensators. For example, thesubstance may be directed from the tissue thickness compensators towardincised and stapled tissue. In another example, a first tissue thicknesscompensator may include a first substance and a second thicknesscompensator may include a second substance, wherein the first and secondsubstances may be mixed by the surgical device. As another example, thesubstances may be directed away from each other, toward a staplecartridge, and/or toward an anvil of the surgical device, for example.

FIGS. 390-391 illustrate a surgical stapling system that includes acutting blade 19000 comprising a cutting edge 19016, a staple cartridge19002, an anvil 19008, a first tissue thickness compensator 19004positioned on the staple cartridge 19002, and a second tissue thicknesscompensator 19006 positioned on the anvil 19008. In use, the cuttingblade 19000 is moved distally in the direction of arrow D to cut patienttissue T and the first and second tissue thickness compensators 19004and 19006. In various embodiments, the first tissue thicknesscompensator 19004 comprises a substance S contained therein and thesecond tissue thickness compensator 19006 comprises a substance S′contained therein. In various embodiments, the first tissue thicknesscompensator 19004 includes an encasement that includes the substance Stherein. The encasement may include a film of material that is opened bythe cutting blade 19000 cutting the film, wherein the substance S isreleased when the film is opened. The second tissue thicknesscompensator 19006 may include a similar encasement, and the secondsubstance S′ may be released when the encasement of the second tissuethickness compensator 19006 is cut open by the cutting blade 19000. Asthe blade 19000 moves distally, guides 19030 and 19022 may direct ordisplace substances S and S′ from the first and second tissue thicknesscompensators 19004 and 19006, respectively. For example, substances Sand S′ may be directed toward the incised tissue T. The blade 19000 maybe coupled to a shaft 19012, which, in turn, may be connected to anactuating mechanism that moves the blade 19000 in the distal direction Dand in a proximal direction indicated by arrow P.

A guide 19030 may direct the substance S from the first tissue thicknesscompensator 19004 towards the incised tissue T. A mirror-image of theguide 19030 may be positioned on an opposing face of the blade 19000.Guide 19030 may include two raised ridges 19032 and 19034 that define achannel C therebetween. A distal end 19035 of the channel C can bepositioned proximate to the first tissue thickness compensator 19004 anda proximal end 19037 of the channel C can be positioned proximate to thetissue T when the surgical stapler is positioned against the tissue T.In use, as the cutting blade 19000 moves in the distal direction D, thesubstance S from the first tissue thickness compensator 19004 enters thechannel C at distal end 19035, flows through the channel C, and exitsthe channel C at proximal end 19037 proximate to the tissue T.

A guide 19022 may direct substance S′ from the second tissue thicknesscompensator 19006 toward the incised tissue T. Guide 19022 includes aprotrusion 19025 with an inclined surface 19023. As shown in FIG. 61,the protrusion 19025 may pierce or cut the second tissue thicknesscompensator 19006 to release the substance S′. As the blade 19000 movesdistally D, the inclined surface 19025 can direct the substance S′towards the tissue T.

Substances S and S′ may mix as they are directed towards the tissue T.The substances S and S′ may be different and may react when mixed. Forexample, substances S and S′ may react chemically when mixed to form anew substance S″. The new substance S″ may be, for example, amedication, an antibiotic, a coagulant, and/or any other suitable typeof substance. After the blade 19000 has been suitably advanced in thedistal direction D, the blade 19000 may return by moving proximally Pwherein the proximal movement of the blade 19000 may further mixsubstances S and S′.

Alternatively, the guides 19022 and 19030 may be configured to directsubstances S and S′ away from tissue T. For example, guide 19030 may beconfigured to direct substance S toward the staple cartridge 19002, andguide 19022 may be configured to direct substance S′ toward the anvil19008. Such an arrangement may be advantageous, for example, if thefirst tissue thickness compensator 19004 is held to the staple cartridge19002 by an adhesive at a junction 19005, for example, and if the secondtissue thickness compensator 19906 is held to the anvil 19008 by anadhesive at a junction 19007, for example. The substances S and S′ maydissolve or neutralize the adhesives, thereby at least partiallyreleasing the first and second tissue thickness compensators 19004 and19006 from the staple cartridge 19002 and the anvil 19008, respectively.

FIG. 63 shows an alternative guide 19030′ in which a channel C′ isdefined by a depression or groove in the surface of the blade 19014. Thechannel C′ may comprise a single channel or may comprise multiplechannels.

FIGS. 64-67 illustrate another surgical stapling system that includes acutting blade 19060 and a cutting edge 19056, a first tissue thicknesscompensator 19004, and a second tissue thickness compensator 19006. Theblade 19060 may include a first protrusion 19062 on a first side of theblade 19060, wherein the first protrusion 19062 defines an orifice 19064passing from the first side of the blade 19060 to a second side of theblade 19060. In various embodiments, the first protrusion 19062 andfirst orifice 19064 may be aligned with the first tissue thicknesscompensator 19004. In use, as the blade 19060 moves distally, at least aportion of the substance S in the first tissue thickness compensator19004 can pass through the first orifice 19064. In various embodiments,contours of the first protrusion 19062 can direct the substance S to asecond side of the blade 19060 and/or toward the tissue T.

The blade 19060 may also include a second protrusion 19066 on the secondside of the blade 19060, wherein the second protrusion defines anorifice 19068 passing from the second side of the blade 19060 to thefirst side of the blade 19060. In various embodiments, the secondprotrusion 19066 and the second orifice may be aligned with the secondtissue thickness compensator 19006. In use, as the blade 19060 movesdistally, at least a portion of the substance S′ in the tissue thicknesscompensator 19006 can pass through the second orifice 19068. In variousembodiments, contours of the second protrusion 19066 can direct thesubstance S′ to the first side of the blade 19060 and/or toward thetissue T.

Referring primarily to FIGS. 64 and 65, the shaft 19059 may includesurface features, such as, for example, dimples 19070 that can increaseturbulence and/or displacement of the substances S and S′. Thisincreased turbulence and/or displacement can cause a greater portion ofthe substances S and S′ to come into contact with each other, forexample. In at least one embodiment, the dimples 19070 can be positionedproximally with respect to the orifices 19064 and 19068. When the blade19000 is being advanced distally, the dimples 19070 can be downstream ofthe orifices 19064 and 19068; however, when the blade 19000 is refractedproximally, the dimples 19070 can be upstream of the orifices 19064 and19068.

FIGS. 68-70 illustrate another surgical stapler that includes a blade19100 and a cutting edge 19108, a first tissue thickness compensator19120, and a second tissue thickness compensator 19122. In variousembodiments, the first tissue thickness compensator 19120 can comprise afirst substance S and a second substance S′. For example, the firstsubstance S can be contained in a first encasement, described above. Thesecond substance S′ can be carried in a second encasement that can beproximate to and/or surrounding the first encasement. In variousembodiments, the second tissue thickness compensator 19122 can comprisea third substance S″. In various embodiments, the second tissuethickness compensator 1922 can comprise a fourth substance S′″. Thethird substance S′″ and the fourth substance S′″ may be carried inencasements, like the encasements described above. The blade 19100 mayinclude a textured surface 19110 on a first side 19102 of the blade19100 on which substances S, S′, S″, and S′″ can spread across. Anothertextured surface may be located on an opposing second side (not shown)of the blade 19100. The textured surface 19110 may comprise a series ofdisrupting features, such as, for example, grooves that are cut, scored,etched, and/or otherwise formed in the first surface 19102. Thedisrupting features also may comprise a series of raised features, suchas raised ridges, on the first surface 19102, for example. As shown inFIGS. 68-70, the disrupting features of the textured surface 19110 mayinclude a regularly repeating pattern of disrupting features. Thedisrupting features may also be placed in a non-repeating pattern orrandomly placed.

The blade 19100 may also include a second surface 19104 that ispositioned proximally relative to the first surface 19102. In variousembodiments, the second surface 19104 can be raised relative to thefirst surface 19102. A junction between the first surface 19102 and thesecond surface 19104 can define a third surface 19106, wherein the thirdsurface 19106 may be positioned at an angle relative to a longitudinalaxis of the blade 19100. In various embodiments, the motion of the blade19100 in the distal direction D can result in a first end 19107 of thethird surface 19106 leading ahead of a second end 19109 of the thirdsurface 19106. As a result, as shown in FIG. 70, the third surface 19106can cause the substances S and S′ from the first tissue thicknesscompensator 19120 to be directed toward the incised tissue T. A surface19105, similar to the second surface 19104, may be located on theopposing second side of the blade 19100.

The blade 19100 shown in FIGS. 68-70 may be used in a surgical devicethat includes the first and second tissue thickness compensators 19004and 19006 shown in FIGS. 61-67. As described above, the textured surface19110 may distribute the substances S and S′ from respective tissuethickness compensators 19004 and 19006 on the first surface 19102 of theblade such that they may mix and can be positioned near the tissue T.

The blade 19100 shown in FIGS. 68-70 also may be used in a surgicaldevice that includes the first tissue thickness compensator 19120 andthe second tissue thickness compensator 19122 shown in FIGS. 68-70. Thefirst tissue thickness compensator 19120 may include an interior portion19121 that includes a first substance S. When the first tissue thicknesscompensator 19120 is cut by the cutting edge 19108 of the blade 19100,the substance S can be released from the interior portion 19121. As theblade 19100 moves relative to the tissue thickness compensator 19120,the substance S may be spread on the textured surface 19110 and thethird surface 19106 can direct the substance S toward the tissue T. Asdescribed above, in various embodiments, the first tissue thicknesscompensator 19120 may include a second substance S′ outside of theinterior portion 19121. When the first tissue thickness compensator19120 is cut by the cutting edge 19108 of the blade 19100, both thefirst substance S and the second substance S′ may be distributed on thetextured surface 19110. The distribution on the textured surface 19110may cause the first substance S and the second substance S′ to mix. Whenmixed, the first substance S and the second substance S′ may react, suchas, for example, chemically reacting to form a new substance. The thirdsurface 19106 may direct the first substance S and the second substanceS′ towards the tissue. As described above, in various embodiments, thesecond tissue thickness compensator 19122 may include a third substanceS″. When the second tissue thickness compensator 19122 is cut by thecutting edge 19108 of the blade 19100, the third substance S″ may bedistributed on the textured surface 19110 where it may mix with thefirst substance S and/or the second substance S′ and be directed towardsthe tissue T. As described above, in various embodiments, the secondtissue thickness compensator 19122 may include a fourth substance S′″.When the second tissue thickness compensator 19122 is cut by the cuttingedge 19108 of the blade 19100, the third substance S″ and the fourthsubstance S′″ may be distributed on the textured surface 19110 wherethey may mix with the first substance S, the second substance S′ and/oreach other and can be directed towards the tissue T.

In various embodiments, further to the above, a tissue thicknesscompensator can be comprised of a biocompatible material. Thebiocompatible material, such as, a foam, may comprise tackifiers,surfactants, fillers, cross-linkers, pigments, dyes, antioxidants andother stabilizers and/or combinations thereof to provide desiredproperties to the material. In certain embodiments, a biocompatible foammay comprise a surfactant. The surfactant may be applied to the surfaceof the material and/or dispersed within the material. Without wishing tobe bound to any particular theory, the surfactant applied to thebiocompatible material may reduce the surface tension of the fluidscontacting the material. For example, the surfactant may reduce thesurface tension of water contacting the material to accelerate thepenetration of water into the material. In various embodiments, thewater may act as a catalyst. The surfactant may increase thehydrophilicity of the material.

In various embodiments, the surfactant may comprise an anionicsurfactant, a cationic surfactant, and/or a non-ionic surfactant.Examples surfactants include, but are not limited to polyacrylic acid,methalose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, carboxy methyl cellulose, polyoxyethylene cetyl ether,polyoxyethylene lauryl ether, polyoxyethylene octyl ether,polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether,polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether,polyoxyethylene nonylphenyl ether, dialkylphenoxy poly(ethyleneoxy)ethanol, and polyoxamers, and combinations thereof. In at least oneembodiment, the surfactant may comprise a copolymer of polyethyleneglycol and polypropylene glycol. In at least one embodiment, thesurfactant may comprise a phospholipid surfactant. The phospholipidsurfactant may provide antibacterial stabilizing properties and/ordisperse other materials in the biocompatible material.

In various embodiments, the tissue thickness compensator may comprise atleast one medicament. The tissue thickness compensator may comprise oneor more of the natural materials, non-synthetic materials, and/orsynthetic materials described herein. In certain embodiments, the tissuethickness compensator may comprise a biocompatible foam comprisinggelatin, collagen, hyaluronic acid, oxidized regenerated cellulose,polyglycolic acid, polycaprolactone, polyactic acid, polydioxanone,polyhydroxyalkanoate, poliglecaprone, and combinations thereof. Incertain embodiments, the tissue thickness compensator may comprise afilm comprising the at least one medicament. In certain embodiments, thetissue thickness compensator may comprise a biodegradable filmcomprising the at least one medicament. In certain embodiments, themedicament may comprise a liquid, gel, and/or powder. In variousembodiments, the medicaments may comprise anticancer agents, such as,for example, cisplatin, mitomycin, and/or adriamycin.

In various embodiments, the tissue thickness compensator may comprise abiodegradable material to provide controlled elution of the at least onemedicament as the biodegradable material degrades. In variousembodiments, the biodegradable material may degrade may decompose, orloses structural integrity, when the biodegradable material contacts anactivator, such as, for example an activator fluid. In variousembodiments, the activator fluid may comprise saline or any otherelectrolyte solution, for example. The biodegradable material maycontact the activator fluid by conventional techniques, including, butnot limited to spraying, dipping, and/or brushing. In use, for example,a surgeon may dip an end effector and/or a staple cartridge comprisingthe tissue thickness compensator comprising the at least one medicamentinto an activator fluid comprising a salt solution, such as sodiumchloride, calcium chloride, and/or potassium chloride. The tissuethickness compensator may release the medicament as the tissue thicknesscompensator degrades. In certain embodiments, the elution of themedicament from the tissue thickness compensator may be characterized bya rapid initial elution rate and a slower sustained elution rate.

In various embodiments, a tissue thickness compensator, for example, canbe comprised of a biocompatible material which may comprise an oxidizingagent. In various embodiments, the oxidizing agent may an organicperoxide and/or an inorganic peroxide. Examples of oxidizing agents mayinclude, but are not limited to, hydrogen peroxide, urea peroxide,calcium peroxide, and magnesium peroxide, and sodium percarbonate. Invarious embodiments, the oxidizing agent may comprise peroxygen-basedoxidizing agents and hypohalite-based oxidizing agents, such as, forexample, hydrogen peroxide, hypochlorous acid, hypochlorites,hypocodites, and percarbonates. In various embodiments, the oxidizingagent may comprise alkali metal chlorites, hypochlorites and perborates,such as, for example, sodium chlorite, sodium hypochlorite and sodiumperborate. In certain embodiments, the oxidizing agent may comprisevanadate. In certain embodiments, the oxidizing agent may compriseascorbic acid. In certain embodiments, the oxidizing agent may comprisean active oxygen generator. In various embodiments, a tissue scaffoldmay comprise the biocompatible material comprising an oxidizing agent.

In various embodiments, the biocompatible material may comprise aliquid, gel, and/or powder. In certain embodiments, the oxidizing agentmay comprise microparticles and/or nanoparticles, for example. Forexample, the oxidizing agent may be milled into microparticles and/ornanoparticles. In certain embodiments, the oxidizing agent may beincorporated into the biocompatible material by suspending the oxidizingagent in a polymer solution. In certain embodiments, the oxidizing agentmay be incorporated into the biocompatible material during thelyophylization process. After lyophylization, the oxidizing agent may beattached to the cell walls of the biocompatible material to interactwith the tissue upon contact. In various embodiments, the oxidizingagent may not be chemically bonded to the biocompatible material. In atleast one embodiment, a percarbonate dry power may be embedded within abiocompatible foam to provide a prolonged biological effect by the slowrelease of oxygen. In at least one embodiment, a percarbonate dry powermay be embedded within a polymeric fiber in a non-woven structure toprovide a prolonged biological effect by the slow release of oxygen. Invarious embodiments, the biocompatible material may comprise anoxidizing agent and a medicament, such as, for example, doxycycline andascorbic acid.

In various embodiments, the biocompatible material may comprise a rapidrelease oxidizing agent and/or a slower sustained release oxidizingagent. In certain embodiments, the elution of the oxidizing agent fromthe biocompatible material may be characterized by a rapid initialelution rate and a slower sustained elution rate. In variousembodiments, the oxidizing agent may generate oxygen when the oxidizingagent contacts bodily fluid, such as, for example, water. Examples ofbodily fluids may include, but are not limited to, blood, plasma,peritoneal fluid, cerebral spinal fluid, urine, lymph fluid, synovialfluid, vitreous fluid, saliva, gastrointestinal luminal contents, and/orbile. Without wishing to be bound to any particular theory, theoxidizing agent may reduce cell death, enhance tissue viability and/ormaintain the mechanical strength of the tissue to tissue that may bedamaged during cutting and/or stapling. In various embodiments, thebiocompatible material may comprise at least one microparticle and/ornanoparticle. The biocompatible material may comprise one or more of thenatural materials, non-synthetic materials, and synthetic materialsdescribed herein. In various embodiments, the biocompatible material maycomprise particles having a mean diameter of about 10 nm to about 100 nmand/or about 10 μm to about 100 μm, such as, for example, 45-50 nmand/or 45-50 μm. In various embodiments, the biocompatible material maycomprise biocompatible foam comprising at least one microparticle and/ornanoparticle embedded therein. The microparticle and/or nanoparticle maynot be chemically bonded to the biocompatible material. Themicroparticle and/or nanoparticle may provide controlled release of themedicament. In certain embodiments, the microparticle and/ornanoparticle may comprise at least one medicament. In certainembodiments, the microparticle and/or nanoparticle may comprise ahemostatic agent, an anti-microbial agent, and/or an oxidizing agent,for example. In certain embodiments, the tissue thickness compensatormay comprise a biocompatible foam comprising an hemostatic agentcomprising oxidized regenerated cellulose, an anti-microbial agentcomprising doxycline and/or Gentamicin, and/or an oxidizing agentcomprising a percarbant. In various embodiments, the microparticleand/or nanoparticle may provide controlled release of the medicament upto three days, for example.

In various embodiments, the microparticle and/or nanoparticle may beembedded in the biocompatible material during a manufacturing process.For example, a biocompatible polymer, such as, for example, a PGA/PCL,may contact a solvent, such as, for example, dioxane to form a mixture.The biocompatible polymer may be ground to form particles. Dryparticles, with or without ORC particles, may be contacted with themixture to form a suspension. The suspension may be lyophilized to forma biocompatible foam comprising PGA/PCL having dry particles and/or ORCparticles embedded therein.

In various embodiments, the tissue thickness compensators or layersdisclosed herein can be comprised of an absorbable polymer, for example.In certain embodiments, a tissue thickness compensator can be comprisedof foam, film, fibrous woven, fibrous non-woven PGA, PGA/PCL(Poly(glycolic acid-co-caprolactone)), PLA/PCL (Poly(lacticacid-co-polycaprolactone)), PLLA/PCL, PGA/TMC (Poly(glycolicacid-co-trimethylene carbonate)), PDS, PEPBO or other absorbablepolyurethane, polyester, polycarbonate, Polyorthoesters, Polyanhydrides,Polyesteramides, and/or Polyoxaesters, for example. In variousembodiments, a tissue thickness compensator can be comprised of PGA/PLA(Poly(glycolic acid-co-lactic acid)) and/or PDS/PLA(Poly(p-dioxanone-co-lactic acid)), for example. In various embodiments,a tissue thickness compensator can be comprised of an organic material,for example. In certain embodiments, a tissue thickness compensator canbe comprised of Carboxymethyl Cellulose, Sodium Alginate, Cross-linkedHyaluronic Acid, and/or Oxidized regenerated cellulose, for example. Invarious embodiments, a tissue thickness compensator can comprise adurometer in the 3-7 Shore A (30-50 Shore OO) ranges with a maximumstiffness of 15 Shore A (65 Shore OO), for example. In certainembodiments, a tissue thickness compensator can undergo 40% compressionunder 3 lbf load, 60% compression under 6 lbf load, and/or 80%compression under 20 lbf load, for example. In certain embodiments, oneor more gasses, such as air, nitrogen, carbon dioxide, and/or oxygen,for example, can be bubbled through and/or contained within the tissuethickness compensator. In at least one embodiment, a tissue thicknesscompensator can comprise beads therein which comprise betweenapproximately 50% and approximately 75% of the material stiffnesscomprising the tissue thickness compensator.

In various embodiments, a tissue thickness compensator can comprisehyaluronic acid, nutrients, fibrin, thrombin, platelet rich plasma,Sulfasalazine (Azulfidine®−5ASA+Sulfapyridine diazobond))−prodrug−colonic bacterial (Azoreductase), Mesalamine (5ASA withdifferent prodrug configurations for delayed release), Asacol®(5ASA+Eudragit-S coated−pH>7 (coating dissolution)), Pentasa®(5ASA+ethylcellulose coated−time/pH dependent slow release), Mesasal®(5ASA+Eudragit-L coated−pH>6), Olsalazine (5ASA+5ASA−colonic bacterial(Azoreductase)), Balsalazide (5ASA+4Aminobenzoyl-B-alanine)−colonicbacterial (Azoreductase)), Granulated mesalamine, Lialda (delay and SRformulation of mesalamine), HMPL-004 (herbal mixture that may inhibitTNF-alpha, interleukin-1 beta, and nuclear-kappa B activation), CCX282-B(oral chemokine receptor antagonist that interferes with trafficking ofT lymphocytes into the intestinal mucosa), Rifaximin (nonabsorbablebroad-spectrum antibiotic), Infliximab, murine chymieric (monoclonalantibody directed against TNF-alpha-approved for reducing signs/symptomsand maintaining clinical remission in adult/pediatric patients withmoderate/severe luminal and fistulizing Crohn's disease who have hadinadequate response to conventional therapy), Adalimumab, Total HumanIgG1 (anti-TNF-alpha monoclonal antibody—approved for reducingsigns/symptoms of Crohn's disease, and for the induction and maintenanceof clinical remission in adult patients with moderate/severe activeCrohn's disease with inadequate response to conventional therapies, orwho become intolerant to Infliximab), Certolizumab pegoll, humanizedanti-TNF FAB′ (monoclonal antibody fragment linked to polyethyleneglycol—approved for reducing signs/symptoms of Crohn's disease and forthe induction and maintenance of response in adult patients w/moderate/severe disease with inadequate response to conventionaltherapies), Natalizumab, First non-TNF-alpha inhibitor (biologiccompound approved for Crohn's disease), Humanized monoclonal IgG4antibody (directed against alpha-4 integrin—FDA approved for inducingand maintaining clinical response and remission in patients withmoderate/severe disease with evidence of inflammation and who have hadinadequate response to or are unable to tolerate conventional Crohn'stherapies and inhibitors of TNF-alpha), concomitant Immunomodulatorspotentially given with Infliximab, Azathioprine 6-Mercaptopurine (purinesynthesis inhibitor—prodrug), Methotrexate (binds dihydrofolatereductase (DHFR) enzyme that participates in tetrahydrofolate synthesis,inhibits all purine synthesis), Allopurinol and Thioprine therapy, PP1,H2 for acid suppression to protect the healing line, C-Diff—Flagyl,Vancomycin (fecal translocation treatment; probiotics; repopulation ofnormal endoluminal flora), and/or Rifaximin (treatment of bacterialovergrowth (notably hepatic encephalopathy); not absorbed in GI tractwith action on intraluminal bacteria), for example.

As described herein, a tissue thickness compensator can compensate forvariations in the thickness of tissue that is captured within thestaples ejected from a staple cartridge and/or contained within a stapleline, for example. Stated another way, certain staples within a stapleline can capture thick portions of the tissue while other staples withinthe staple line can capture thin portions of the tissue. In suchcircumstances, the tissue thickness compensator can assume differentheights or thicknesses within the staples and apply a compressive forceto the tissue captured within the staples regardless of whether thecaptured tissue is thick or thin. In various embodiments, a tissuethickness compensator can compensate for variations in the hardness ofthe tissue. For instance, certain staples within a staple line cancapture highly compressible portions of the tissue while other stapleswithin the staple line can capture portions of the tissue which are lesscompressible. In such circumstances, the tissue thickness compensatorcan be configured to assume a smaller height within the staples thathave captured tissue having a lower compressibility, or higher hardness,and, correspondingly, a larger height within the staples that havecaptured tissue having a higher compressibility, or lower hardness, forexample. In any event, a tissue thickness compensator, regardless ofwhether it compensates for variations in tissue thickness and/orvariations in tissue hardness, for example, can be referred to as a‘tissue compensator’ and/or as a ‘compensator’, for example.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

1. A method of manufacturing a tissue thickness compensator, said methodcomprising the steps of: preparing a solution comprising a hydrophilicmaterial; dissolving a medicament into said solution; mixing thesolution with a hydrophobic material; pouring the solution into a mold;and lyophilizing the solution.
 2. The method of claim 1, wherein saidlyophilizing step comprises the steps of placing the mold in a vacuumchamber, reducing the atmospheric pressure within the vacuum chamber,and lowering the temperature within the vacuum chamber.
 3. The method ofclaim 1, wherein said lyophilizing step produces a sheet of material,and wherein said method further comprises the step of dissecting thesheet of material.
 4. The method of claim 1, wherein the medicamentdissolves into microparticles within the solution during said dissolvingstep.
 5. The method of claim 4, wherein the microparticles are suspendedin the hydrophobic material after said mixing step.
 6. A tissuethickness compensator for use with a fastening instrument, said tissuethickness compensator comprising a compressible layer configured to beat least partially captured by fasteners; and a plurality of capsulesembedded in said compressible layer.
 7. The tissue thickness compensatorof claim 6, wherein the fastening instrument comprises an anvil, andwherein said tissue thickness compensator comprises an attachmentportion configured to be attached to the anvil.
 8. The tissue thicknesscompensator of claim 6, wherein said compressible layer comprises atissue-contacting surface, and wherein said capsules are embedded insaid tissue-contacting surface.
 9. The tissue thickness compensator ofclaim 6, wherein each said capsule comprises a frangible shell.
 10. Thetissue thickness compensator of claim 6, wherein said plurality ofcapsules comprises first capsules and second capsules, wherein saidfirst capsules are comprised of a first medicament, and wherein saidsecond capsules are comprised of a second medicament which is differentthan said first medicament.
 11. The tissue thickness compensator ofclaim 10, wherein said first capsules and said second capsules arearranged along a path in an alternating arrangement.
 12. The tissuethickness compensator of claim 11, wherein said compressible layercomprises channels extending from said capsules, and wherein saidchannels are configured to convey said first medicament and said secondmedicament.
 13. The tissue thickness compensator of claim 12, whereinsaid anvil includes a plurality of recesses, and wherein each saidrecess is configured to receive a said capsule.
 14. A staple cartridge,comprising: a cartridge body comprising a deck and staple cavitiesdefined in said deck; staples, wherein each said staple is at leastpartially positioned in a said staple cavity, and wherein said staplesare movable between unfired positions and fired positions; acompressible tissue thickness compensator, wherein said staples at leastpartially extend into said tissue thickness compensator, and whereinsaid staples are configured to at least partially capture said tissuethickness compensator when they are moved between said unfired positionsand said fired positions; and a substrate positioned intermediate saidtissue thickness compensator and said deck.
 15. The staple cartridge ofclaim 14, wherein said substrate comprises a plurality of enclosed tubesincluding a medicament positioned therein.
 16. The staple cartridge ofclaim 15, wherein said enclosed tubes are aligned with said staples. 17.The staple cartridge of claim 15, wherein said cartridge body furthercomprises a slot configured to receive a cutting member, wherein saidenclosed tubes extend over said slot, and wherein said enclosed tubesare configured to be incised by the cutting member to release saidmedicament contained therein.
 18. The staple cartridge of claim 17,wherein each said enclosed tube extends along a tube axis, and whereineach said tube axis extends in a direction transverse to said slot. 19.The staple cartridge of claim 15, wherein said medicament comprises afluid.
 20. The staple cartridge of claim 14, wherein each said staplecomprises at least one staple leg, wherein said substrate comprises aplurality of apertures, and wherein said staple legs extend through saidapertures.
 21. The staple cartridge of claim 14, wherein saidcompressible tissue compensator is attached to said substrate.